Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : October | Volume : 16 | Issue : 10 | Page : PC05 - PC10 Full Version

Comparison of Offloading Dressing with Conventional Dressing in Healing of Plantar Diabetic Foot Ulcers: A Randomised Clinical Trial


Published: October 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/49942.16999
Shraddha Modi, T Tirou Aroul

1. Postgraduate, Department of General Surgery, Mahatma Gandhi Medical College and Research Institute, Gulbarga, Karnataka, India. 2. Professor, Department of General Surgery, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, ECR Cuddalore Road, Pondicherry, India.

Correspondence Address :
Shraddha Modi,
Modi Bld, Fort Road Kalaburagi, Gulbarga, Karnataka, India.
E-mail: shraddha.modi1310@gmail.com

Abstract

Introduction: The first ever description of Diabetic Foot Ulcers (DFUs), made in the literature was in the mid 19th century. The management principles for it were laid by late 19th century and are still being followed. For a chronic DFU to heal, offloading of pressure, surgical debridement, correction of hyperglycaemia, the use of antibiotics are the corner stone of management. Offloading is an essential modality of prevention and treatment of recurrent plantar DFU.

Aim: To compare offloading dressing to conventional dressing in promoting healing of diabetic plantar foot ulcers.

Materials and Methods: This randomised clinical trial was conducted at Mahatma Gandhi Medical College and Research Institute, Pondicherry, India, between January 2019 to June 2020 among the patients with DFU coming to the Department of General Surgery. A total of 44 patients were included in the study, 22 of these patients underwent offloading dressing and 22 underwent conventional dressing and these patients were followed-up for a duration of 6 weeks and compared on 2nd, 4th and 6th weeks. The patients were compared according to age, gender, duration of diabetes, glycaemic control, risk factors, previous surgery such as wound debridement or previous toe amputation, vascular assessment and site of ulcer, reduction in size of ulcer. The ulcers in both the groups were classified according to the Wagener’s grading of ulcer classification. All data collected was entered into Microsoft Excel 2016 and analysed using Statistical Package for the Social Sciences (SPSS) version 16.0 (IBM SPSS, US) software. A p-value less than 0.05 was considered as statistically significant.

Results: Among 44 patients, there was equal number of males and females in both the groups, with the total mean age 53.97±10.10 years. The majority of the study population belonged to the 5th decade (51-60 years), where the youngest patient was of 29 years and oldest was of 72 years. There were 22 patients in offloading group and 24 patients in conventional dressing groupas one patient had bilateral plantar ulcers and one patient had two separate ulcers on the plantar aspect of the foot. Total of 45.45% in conventional group and 31.82% of the study population in offloading group had diabetes for 5-10 years of duration. Bad glycaemic control was seen in 40.90% of offloading group and 50% in conventional group. The size reduction percentage of ulcers on comparing both the groups was found to be significant for 2nd week review (p-value=0.03) and was nearly significant for the 6th week review (p-value=0.05).

Conclusion: Summarising the above conducted study, offloading dressing was found to be a more efficacious alternative to the conventional dressing as there was greater difference observed in the reduction of the size of ulcer and the patients in the conventional group needed more number of dressings and the duration of healing in the two groups.

Keywords

Peripheral arterial disease, Shoe model cast, Total contact cast

Until 19th century, Diabetic Foot Ulcers (DFUs) were treated with prolonged bed rest, however the wounds returned once the patient started mobilising (1). Until the end of 19th century, Fredrick Treves had laid the three most important principles for treatment of ulceration of foot: sharp debridement, offloading pressure and education about foot care which have continued to be followed-up until now (1).

India is considered as the diabetes capital of world with an increase in the population from 26 million (1990) to 65 million (2016), with a fair chance of reaching the alarming mark of 69.9 million by 2025 and 80 million by 2030 (2). The pathophysiology behind a DFU is multifactorial and can be attributed to many causes, leading cause being increased plantar foot pressure, mechanical changes occurring in conformation of the bony architecture of the foot, peripheral neuropathy and atherosclerotic peripheral arterial disease, all of these factors occur with higher frequency and intensity in the diabetic population (3).

Offloading is an essential modality of prevention and treatment of plantar diabetic foot ulcers. Various offloading modalities such as Total Contact Cast (TCC), Removable Contact Cast (RCC), Customised therapeutic footwear, Shoe Model Cast (SMC) exist, but all these have their own advantages and disadvantages (4). Majorly being lack of availability for the rural diabetic population even if available, are not affordable for common man.

In this day-to-day advances happening in medical science from application of 3D bioprinting for diabetic foot ulcers to use of economical ways such as mandakini dressing for offloading DFU (5),(6). Each method has its own application process but it all lies down on same ideology of redistributing the pressure in the foot and offloading the ulcer, some methods have tedious process of usage therefore lack of comprehension from the patient side is noted.

Therefore, the aim of the present study was to compare an offloading dressing with a conventional dressing based on its efficacy in reduction in size of the ulcer and cost-effectiveness which can be put to use by all the classes of patients irrespective of their socioeconomical background.

Material and Methods

This randomised clinical trial was conducted in the Department of Surgery at a tertiary care institute (Mahatma Gandhi Medical College and Research Institute), Pondicherry, India, between January 2019 to June 2020. The study population included all the patients with plantar DFUs visiting the Department of General Surgery at MGMCRI during the study period. The study protocol was approved by the Institutional Human Ethics Committee (IHEC). PG DISSERTATION/02/2019/42 dated 26/02/2019.

Inclusion and Exclusion criteria: Patients with plantar DFU Wagner’s grade I, II and III above 18 years of age were included in the study (7),(8). Ulcers of Wagner’s grade IV and V were excluded as they involve deeper underlying tissue with extensive destruction sometimes extending into tendon, ligament or bone. Patients on corticosteroids, receiving radiation therapy and immunosuppressant and DFU with peripheral vascular diseases (ABPI <0.4) were also excluded.

Peripheral arterial disease in DFUs is associated with the most severe adverse outcomes, including lower probability of healing, longer healing times, higher probability of ulcer recurrence, greater risk of toe as well as major amputations, and potentially higher mortality (9). A total of 60 patients with plantar DFUs reporting to the Department of Surgery were recruited for the study.

Sample size estimation: However, due to the global pandemic and its effects on healthcare system, the sample size of study had to be reduced to 22 patients in each group after a formal approval by the Ethical Committee. Therefore, 44 patients were a part of the final clinical study.

Procedure

Patients who fulfilled inclusion criteria were included in the study after duly obtaining an informed written consent, a detailed history of all the patients were noted including demographic data, symptomatology, duration of diabetes. A total of 44 patients with plantar DFUs reporting to the Department of Surgery were recruited. The study participants were divided with a computer generated block randomisation method into two groups with block size of 4.

• Offloading dressing group=22 and
• Conventional dressing group=22.

The patients were subjected to clinical examination, vascular assessment {(clinical palpation of peripheral pulses Posterior Tibial Artery (PTA) and Dorsalis Pedis Artery (DPA) as well as hand held doppler assessment)}, and neuropathic assessment of the lower extremity (10),(11). A thorough clinical examination of the patient was conducted to determine the site, size, shape, extent and depth of the ulcer and peripheral pulses.

Patients underwent routine investigations such as Complete blood count, Renal function test with serum electrolytes, urine routine and microscopy, chest X-ray, Electrocardiogram (ECG), and specific investigations such as Fasting Blood Sugar (FBS), Postprandial Blood Sugar (PPBS), Haemoglobin A1c (HbA1c), urine ketones (if blood glucose levels>250 mg/dL) X-ray foot, hand held arterial doppler and pus culture were done, if required.

In this study “Prozole Adhesive Felt Pad” was used as offloading device, (Dynamic Techno Medicals, Aluva, Kerala) after creating a window in accordance with size of the ulcer in the adhesive felt pad according to the size of the ulcer. The ulcer accommodates within the window and is surrounded by the pad which provides it a cushion-like effect and offloads it from the body weight (Table/Fig 1). This offloading device is a low priced and an economic cost saving method. The estimated average cost of each dressing using the offloading device, used for this study was approximately Rs. 58/- per dressing and the average expenditure incurred by a patient for conventional dressing was Rs. 50/- per dressing.

The patients were compared according to age, gender, duration of diabetes, glycaemic control, risk factors (smoking and alcohol consumption), history of previous surgery (wound debridement or previous toe amputations) (11),(12),(13), site of ulcer, Wagner’s grading system (7),(8), vascular assessment, reduction in size of ulcer and number of dressings.

Vascular assessment of the patients were done (9) i.e, if clinically palpable peripheral pulse present or not; as well as, hand held doppler assessment, site of ulcer (forefoot, mid-foot, hind-foot) and reduction in size of ulcer was recorded. The reduction in size of the ulcer was evaluated at 2nd, 4th and 6th week. Flow chart to summarise the sequence is presented in (Table/Fig 2).

Statistical Analysis

All data collected was entered into entered into MS Excel 2016. The statistical analysis was carried out using SPSS version 16.0 (IBM SPSS, US) software. The findings in both the groups were compared and calculated in form of percentage of reduction. The normally distributed continuous variables were expressed as mean±SD and compared using Independent t-test and the non normally distributed variables were presented as median±Interquartile Range (IQR) and compared using the Mann-Whitney U test to assess the p-value. A p-value less than 0.05 was considered as statistically significant.

Results

Among 44 patients, there were equal number of males and females in both the groups, with the total mean age 53.97±10.10 years. The mean age in the offloading group was 55.68±10.92 years and 52.41±7.07 years in the conventional group. The majority of the study population belonged to the 5th decade (51-60 years), where the youngest patient was of 29 years and oldest was of 72 years (Table/Fig 3). Patient had bilateral plantar ulcers and one patient had two separate ulcers on the plantar aspect of the foot. Hence, 24 ulcers in the conventional group and 22 ulcers in the offloading group were assessed. The peak incidence was noted between 41-60 years.

In the studied population, one patient was recently diagnosed with Type 2 Diabetes Mellitus (T2DM) in the offloading group, while there was no recently diagnosed patient in the conventional group. Most of the patients had diabetes for a duration of 5-10 years both in offloading and conventional group which was 31.82% and 45.45% respectively. In offloading group 22.73% and 13.64% in conventional group had duration of diabetes between 11-15 years. One (4.54%) patient in the offloading group had history of recent diagnosis of diabetes and presented with a plantar ulcer of 2 months duration (Table/Fig 4).

In the study population, the glycaemic control was found to be under bad control category in majority of the population. In offloading group, 40.91% and 50% of the conventional population had their HbA1c more than 10. The rest of the 36.36% in offloading group and 31.82% in conventional group had a poor glycaemic control (7.5-10). However, 22.73% of offloading and 18.18% of the conventional population had a good control of the HbA1c (5.7-7) (Table/Fig 5).

In the offloading group, 27.3% of the population were smokers and 31.8% were alcoholics while in the conventional group 31.8% each were smokers and alcoholics. However, there was no significant difference between the two groups regarding the risk factors, smoking and alcohol (p-values were 0.74 and 0.627, respectively) (Table/Fig 6).

In our study, the number of patients with significant history of previous surgery in the foot such as toe amputations, Incision and Drainage (I and D) and wound debridement included 36.4% of the offloading group and 27.3% of conventional group. The rest of the 63.6% in the offloading group and 72.7% in the conventional group had no previous history of surgeries in the foot (Table/Fig 7).

One patient in the offloading group underwent open reduction and internal fixation of the transmetatarsal joint in view of long standing Charcot’s foot with a non healing forefoot ulcer on the plantar aspect. Authors observed that forefoot was the most common site involved in both offloading and conventional group. The most common site of plantar DFU is the heads of 2nd -5th metatarsals followed by the mid-foot. In our study, 4 (18.2%) of offloading group and 6 (27.3%) of conventional group had midfoot lesions (Table/Fig 8).

One patient in the offloading group had an ulcer occupying both the mid foot and hind foot approximately 12 cm2 in size and 4.5% of population had hind foot lesions in both cases and controls.

In the conventional group, one patient was included who had bilateral plantar foot ulcers and one patient had two ulcers in the plantar aspect hence, the sample size was statistically considered as 24 considering these as two separate entities.

While comparing both the groups Wagner’s grading system was applied to assess the ulcer depth, presence of osteomyelitis or gangrene (7),(8). It is the most widely accepted classification system and it was observed that grade 1 ulcers (superficial ulcers) were common in offloading and conventional groups, 72.7% in the former and 77.3% in the latter. Grade 2 ulcers were 13.6% (deep ulcer not involving tendon, capsule or bone with cellulitis without abscess or osteomyelitis) in the offloading group and 18.2% in the conventional group.

There were two patients with grade 3 ulcers (deep ulcer involving tendon, capsule or bone/abscess formation) in the offloading group, both being diabetic foot abscess. These patients were managed with incision and drainage/debridement under antibiotic coverage for one week and were continued with offloading dressing after the abscess was drained. One patient each in the offloading and conventional group had a grade 0 ulcers (no open lesion) (Table/Fig 9).

The 44 patients who were subjected to clinical examination, vascular assessment (clinical as well as doppler), noted that, in vascular assessment Posterior Tibial Artery (PTA) was not clinically palpable in 4 (18.2%) patients in both offloading and conventional group (N=23 as one patient presented with bilateral plantar DFU) while Dorsalis Pedis Artery (DPA) was not clinically palpable in 1 (4.5%) patient in the offloading group and 4 (18.2%) in the conventional group which matched with the monophasic flow in hand held doppler study (Table/Fig 10). While the rest of the patients had biphasic and triphasic flow. Maximum number of patient showed biphasic flow on doppler study and in the offloading group PTA was absent in 4 (18.2%) and DPA was absent in 1 (4.5%) while in the conventional group 4 (18.2%) patients had absent DPA and PTA (Table/Fig 11). The p-value for clinical assessment and hand held doppler for PTA in both the groups was 1 and 0.820 respectively. For DPA, p-value was 0.154 and 0.741 in the former and latter assessment which was not found to be significant (Table/Fig 10),(Table/Fig 11).

Reduction in size of the ulcer at 2nd, 4th and 6 weeks was calculated using mean for 2nd and 4th week and using median±IOR (Interquartile Range) for the 6th week. The p-value was expressed using Independent t-test for the 2nd week and 4th week. However, Mann- Whitney U test was used for the 6th week as it included data with non normal distribution. The size reduction percentage of ulcers on comparing both the groups was found to be significant for 2nd week review (p-value=0.03) and was nearly significant for the 6th week review (p-value=0.05) (Table/Fig 12),(Table/Fig 13).

Total of 13.6% of the patients in offloading group required upto 10 dressings and 86.4% of them required 10-20 dressings. In the conventional group, 9.1% of the population required upto 10 dressings, 63.6% of the population required 11-20 dressings and 27.3% patients required more than 20 dressings in the period of 6 weeks (Table/Fig 14).

On comparing the number of dressings applied for both the groups and its cost effectiveness, the offloading dressing was found to be more cost-effective as the number of dressing required by the offloading group was overall less on comparison with the conventional group. During the follow-up period, one patient in the offloading group and one in the conventional group missed the 6th week review.

Secondary infection of the ulcer was noted in one of the patients in the offloading group and three patients in the conventional group and were managed with antibiotics (inj. augmentin 1.2 g for 5 days duration) and wound debridement and regular dressings. Complete epithelialisation of the ulcer was noted in three patients of the offloading group in the 4th and 6th week. Similarly, in the conventional group one patient showed signs of complete healing of the ulcer with a callosity and two other patients underwent split skin grafting for closure of the raw area due to chronicity of the ulcer. There was no evidence of oedema, skin changes and maceration noted with the offloading device.

Discussion

This randomised controlled trial aimed at comparing the offloading with conventional dressing in healing of diabetic plantar foot ulcers. Both groups were comparable as there was no statistical difference in the parameters studied. Age and gender assessment, vascular assessment, previous foot surgeries and risk factors were not statistically significant in both the groups while the other variables such as reduction in size of ulcer at 2nd week and number of dressings applied was found to be significant. Majority of the study population belonged to the 5th decade (51-60 years) and 10 out of 22 were in this age group. The youngest patient was 29 years of age and oldest 72 years of age. The peak incidence was noted between 41-60 years. The mean age in our study was 53.97±10.10 years. Sinharay K et al., in their study stated that DFU were present in 4.54% of newly diagnosed diabetes mellitus patients (13).

Ragnarson TG and Apelqvist J, in their study concluded that diabetic patients are at high risk of developing foot ulcers and subsequent amputations (14). Frykberg RG et al., in their study stated that in diabetes related amputations, toe amputations are the most common (15). Lane KL et al., in their study aimed at evaluating the association between glycaemic control and the outcomes of wound healing and Lower Extremity Amputation (LEA) in patients with DFUs, they concluded that HbA1c levels more than or equal to 8 and fasting blood glucose more than or equal to 126 mg/dL are associated with increased likelihood of LEA in patients with DFUs (16). Strandness DE et al., concluded in their study that hypercholesterolemia and smoking are the strong risk factors for atherosclerosis mainly seen in the proximal vessels of the lower limb (17). In a meta-analysis conducted by Fu XL et al., showed that smoking had an overall negative effect on the wound healing of diabetic foot individuals (18). Faglia E et al,. concluded osteomyelitis can affect any bone but most frequently the forefoot (90%), followed by the mid-foot (5%) and the hind-foot (5%) (19). Sutkowska E et al., in their study interpreted that the forefoot is the most frequent region of the foot which bears highest pressure on the sole especially in patients with diabetes it is the central part of the forefoot the 2nd and 3rd metatarsal heads. They also stated that females with higher basal metabolic index are more prone to it (20).

In a similar prospective comparative study conducted by Ganesh P and Kannan R over 110 patients with plantar DFU, divided into test (offloaded) and control group (not offloaded), majority of the patients had grade 1 and 2 ulcers. Grade 1 ulcers were seen in 25% and 30% of test and control group population respectively and grade 2 ulcers were noted in 23% of the test group and 32% of control group which is comparable with our study (21). The reduction in size of ulcers on comparing both the groups was found to be significant for 2nd week review (p-value=0.03) and was nearly significant for the 6th week review (p-value=0.05). Ganesh P and Kannan R in their study of over 110 patients with plantar diabetic foot ulcers, divided into test (offloaded) and control group (not offloaded) assessed at 3rd, 4th ,5th and 6th week also found that the mean size of ulcer was 4.5 cm and the mean±SD of test group was (4.36±2.19) cm and in control group is (4.36±2.18) cm. Grade 1 and 2 ulcers were prevalent in both test and control groups and the reduction in wound surface area was significantly higher in test group at 3rd week follow-up (p-value=0.025) at 4th week (p-value=0.015), at 5th week (p-value<0.001) and at 6th week (p-value<0.001) when compared to control group (21).

This offloading device is a low priced and economic method of cost saving. The estimated average cost of each dressing using the offloading device, used for this study was approximately Rs. 58/-per dressing and the average expenditure incurred by a patient for conventional dressing was Rs. 50/- per dressing. However, on comparing the number of dressings applied for both the groups and its cost-effectiveness, the offloading dressing was found to be more cost-effective as the number of dressing required by the offloading group was overall less on comparison with the conventional group and the p-value was found to be significant (p-value=0.03).

Ranade SS et al., conducted a similar study in which they compared variables like number of dressings, cost effectiveness, duration of hospital stay, patient compliance and many other variables and their observations were similar to the present study (22).

Kari SV, in his observational study concluded that, number of dressings used for offloading the diabetic plantar ulcers were significantly lesser. Total 68% patients who undergone offloading dressings required upto 1-5 dressings and 58% patients required more than 10 dressings showing statistical significance between conventional dressing and dressing with offloading technique (6).

Limitation(s)

Limitations experienced in the study was the reduction in sample size due to the coronavirus disease-2019 pandemic affecting the patient care activities which was impacted worldwide.

Conclusion

The policy makers and the clinicians should build strategies aimed at preventing foot ulcers which are cost-effective to be the primary choice for treatment of DFUs. These strategies could be more beneficial if emphasis is laid on strengthening of patient education and awareness of foot care regime. Summarising the above conducted study authors recommend a keen surveillance on patients with recognised risk factors and co-morbidities for the development of foot problems. Regular visit to the foot clinic once a trimester and adequately offloading the foot, we would like to recommend use of offloading dressing upto two weeks or more depending on the size, depth and extent of ulcer followed by use of conventional dressing with customised footwear/ insoles which carry a high value in preventing ulcer recurrence.

Acknowledgement

With great pleasure I express deep gratitude to my teacher, guide and mentor Professor Tirou Aroul for his invaluable support. I am infinitely obliged to my parents Mrs. Sujatha and Chandrashekhar Modi for being my pillar of strength and I dedicate this work to my late grandparents Mrs Anuradha and Dr. Neelkanth Majge. My whole hearted thanks to all the participants of the study.

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DOI and Others

DOI: 10.7860/JCDR/2022/49942.16999

Date of Submission: Apr 16, 2021
Date of Peer Review: Jul 19, 2022
Date of Acceptance: Sep 22, 2022
Date of Publishing: Oct 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Apr 17, 2022
• Manual Googling: Aug 22, 2022
• iThenticate Software: Sep 21, 2022 (11%)

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