An interventional study of High Purity Type-I Collagen-Based Skin Substitute and SOC and Acellular Intact Fish Skin Matrix and SOC in Diabetic Foot Ulcer (DFU), sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara · Not applicable, Interventional, and Treatment
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centres in India and Bangladesh. The study compares patient outcomes using standard wound care with a High Purity Type-I Collagen-Based Skin Substitute against standard wound care with an Acellular Intact Fish Skin Matrix.
The purpose of this study is to compare the safety and efficacy of a high-purity type-I collagen-based skin substitute (HPTC) versus an acellular intact fish-skin matrix (AFSM) in the treatment of diabetic foot ulcers (DFUs), each combined with standardized background wound care. Eligible participants with a Wagner Grade 1-2 target ulcer will be randomized 1:1, stratified by centre and baseline ulcer-size stratum, to receive HPTC or AFSM. The primary outcome is the proportion of participants achieving confirmed complete closure of the target ulcer by Week 12. Outcome assessment (digital planimetry and closure adjudication) is performed by assessors blinded to treatment allocation.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Adichunchanagiri Institute of Medical Sciences, B G Nagara is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The SOC in this study is wound care covering with High Purity Type-I Collagen-Based Skin Substitute applied weekly or as needed, followed by a padded 3-layer dressing (non-adherent porous paraffin gauze; absorbent gauze pads; soft roll and compressive crepe bandage).
Device: High Purity Type-I Collagen-Based Skin Substitute and SOC
The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix applied weekly or as needed, followed by the same padded 3-layer dressing described above.
Device: Acellular Intact Fish Skin Matrix and SOC
Arm A - The SOC in this study is wound care covering with High Purity Type-I Collagen-Based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze, second layer - absorbent gauze pads \& third layer - soft roll and compressive wrap (crepe bandage). For participants enrolled in the optional histopathological sub-study, a 2-mm punch biopsy will be obtained from the wound edge at baseline and on Day 5 under local anesthesia. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, and sectioned at 4 μm for histological and immunohistochemical analysis.
Also known as: HPTC
Arm B - The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze, second layer - absorbent gauze pads \& third layer - soft roll and compressive wrap (crepe bandage). For participants enrolled in the optional histopathological sub-study, a 2-mm punch biopsy will be obtained from the wound edge at baseline and on Day 5 under local anesthesia. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, and sectioned at 4 μm for histological and immunohistochemical analysis.
Also known as: AFSM, Decellularized Fish Dermal Matrix
Proportion of Participants Achieving Confirmed Complete Wound Closure
Complete wound closure is defined as 100% epithelialization of the target ulcer with no drainage and no clinically evident open area requiring dressing, confirmed by a blinded central adjudicator at a follow-up visit approximately 7 days after initial clinical closure is observed.
Time frame: Up to Week 13 (initial closure assessed through Week 12; confirmation visit approximately 7 days later)
Percentage Wound Area Reduction Over Time
Percentage reduction in wound area from baseline, measured by standardized digital photography and central digital planimetry.
Time frame: Weeks 2, 4, 6, 8, and 12
Proportion Achieving ≥50%, ≥75%, and ≥90% Wound-Area Reduction
Proportion of participants achieving each threshold of wound-area reduction relative to baseline.
Time frame: Week 12
Time to Confirmed Complete Wound Closure
Time from randomization to confirmed complete closure of the target ulcer, analyzed by Kaplan-Meier methods.
Time frame: Up to Week 13
Mean Number of Study-Product Applications
Average number of applications of HPTC or AFSM required to achieve wound closure or study completion.
Time frame: Up to Week 6
Number of Participants with Adverse Events
Number of participants experiencing adverse events related to the intervention (e.g., infection, allergic reaction, local irritation).
Time frame: Up to Week 13
Patient-Reported Quality of Life (DFS-SF)
Diabetic Foot Ulcer Scale-Short Form, four subscales (physical functioning, daily activities, emotions, social functioning), 0-100 per subscale, higher = better.
Time frame: Baseline and Week 12
Scar Quality (Vancouver Scar Scale)
Vancouver Scar Scale assessing pigmentation, pliability, height, and vascularity; total score 0-13, lower = better.
Time frame: Week 12 or at confirmed closure
Ulcer Recurrence
Recurrence of the index ulcer after confirmed closure, monitored through study completion.
Time frame: Up to Week 13
Tissue Advanced Glycation End-Product Accumulation (CML)
Quantification of Nε-(carboxymethyl)lysine (CML), a marker of tissue advanced glycation end-product accumulation relevant to impaired diabetic wound healing, in wound-edge biopsy specimens by ELISA (preferred) or immunohistochemistry with anti-CML antibody. Analysis Population Description: Histopathological sub-study subset only (approximately 30-40 participants, balanced between arms, at selected centres) - not assessed in the full 120-participant population.
Time frame: Baseline (Day 0) and Day 5
Quantitative Collagen Organization and Maturation
Collagen density, fibre alignment, fibre orientation, and degree of organization in wound-edge biopsy specimens, assessed by Masson's Trichrome or Picrosirius Red staining with polarized light microscopy and quantified using digital image analysis software (ImageJ or QuPath). Analysis Population Description: Histopathological sub-study subset only.
Time frame: Baseline (Day 0) and Day 5
Microvessel Density and Vascular Maturation
Angiogenesis assessed by CD31 immunohistochemistry (endothelial cell count, microvessel density expressed as vessels per high-power field, and CD31-positive area percentage), and vascular maturation assessed by α-smooth muscle actin (α-SMA) immunohistochemistry (mature/stabilized vessel count and activated myofibroblast density). Analysis Population Description: Histopathological sub-study subset only.
Time frame: Baseline (Day 0) and Day 5
General Histopathological Wound Response (H&E)
Hematoxylin and eosin-stained wound-edge biopsy specimens assessed for inflammatory cell infiltrate, necrosis, epithelial migration, granulation tissue formation, and overall tissue architecture. Analysis Population Description: Histopathological sub-study subset only.
Time frame: Baseline (Day 0) and Day 5
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication, together with the study protocol and statistical analysis plan, will be made available to researchers who provide a methodologically sound proposal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months after publication of the primary manuscript
Access criteria: Requests should be directed to the corresponding author (Dr. Naveen Narayan, naveennumerouno@gmail.com) with a methodologically sound research proposal. Data will be provided after de-identification, subject to a signed data-access agreement, and following approval of the proposal by the trial investigator group.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 6 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Adichunchanagiri Institute of Medical Sciences, B G Nagara