Diabetic Foot Ulcer (DFU)NCT07781917
HPTC Versus AFSM in Diabetic Foot Ulcers
A study testing High Purity Type-I Collagen-Based Skin Substitute and SOC and Acellular Intact Fish Skin Matrix and SOC in people with Diabetic Foot Ulcer (DFU), run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 4 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- High Purity Type-I Collagen-Based Skin Substitute and SOC and Acellular Intact Fish Skin Matrix and SOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 diabetes mellitus.
- Diabetic foot ulcer located below the malleoli, Wagner Grade 1 or 2 (University of Texas Grade 1-2), without exposed bone.
- Target ulcer present for a minimum of 4 weeks, with post-debridement area of approximately 5-20 cm².
- Failure to achieve ≥30% ulcer-area reduction during the run-in period, or an equivalent documented waiver (Section 12.1).
- Adequate circulation to the affected foot: ankle-brachial index (ABI) between 0.7 and 1.3 (or alternative vascular criteria per protocol).
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- Glycated haemoglobin (HbA1c) ≤ 12%.
- The subject must consent to using the prescribed off-loading method for the duration of the study.
- The subject must agree to attend the scheduled study visits required by the protocol.
- The subject must be willing and able to participate in the informed consent process.
- Patients must have read and signed the IEC-approved ICF before screening procedures are undertaken.
Who cannot join
- A subject known to have a life expectancy of less than 6 months.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence; Wagner Grade ≥3.
- A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy.
- Topical application of steroids to the ulcer surface within one month of initial screening.
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- A subject with a previous partial amputation on the affected foot, if the resulting deformity impedes proper offloading of the target ulcer.
- A subject with glycated haemoglobin (HbA1c) greater than 12% at or within 3 months of the initial screening visit.
- A subject with an acute Charcot foot, or an inactive Charcot foot that impedes proper offloading of the target ulcer.
- Women who are pregnant or considering becoming pregnant within the next 6 months.
- A subject with end-stage renal disease requiring dialysis; active malignancy.
- A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- A subject treated with hyperbaric oxygen therapy or a cellular and/or tissue product (CTP) in the 30 days prior to the initial screening visit.
- Known hypersensitivity to HPTC or its components; known fish allergy/hypersensitivity for participants who would be allocated to AFSM.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Bangladesh2 sites, 2 recruiting
- Recruiting
National Institute of Burn & Plastic Surgery
Dhaka, 1000
Shawon B Rahman, MBBS, MS
- Recruiting
EKAGRA Health
Dhaka, 1209
Rashedul M Rashedul, MBBS, FACS
India2 sites, 2 recruiting
- Recruiting
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448
Naveen Narayan, MS, MCh, 9980023372, naveennumerouno@gmail.com
Chethan Shivannaiah, DNB, drschethan@gmail.com
- Recruiting
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001
Vijay Kumar, MS, MCh, 9141716348, naveen_uno1@yahoo.co.in
Vijay Kumar, MS, MCh
About this study
Official title: A Multicentric, Randomized, Controlled Clinical Trial Comparing High-Purity Type-I Collagen-Based Skin Substitute Versus Acellular Intact Fish Skin Matrix in the Treatment of Diabetic Foot Ulcers
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.
Read the detailed description
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.
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- High Purity Type-I Collagen-Based Skin Substitute and SOC, Acellular Intact Fish Skin Matrix and SOC
- Keywords
- Diabetic Foot Ulcer;, High Purity Type-I Collagen-Based Skin Substitute;, Acellular Intact Fish Skin Matrix;, Randomized Controlled Clinical Trial;, Multicentric Study;, Dermal Matrix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Purity Type-I Collagen-Based Skin Substitute and SOCDevice
Also called HPTC
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.
Acellular Intact Fish Skin Matrix and SOCDevice
Also called AFSM, Decellularized Fish Dermal Matrix
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.
| Study group | Role | What they receive |
|---|---|---|
| High Purity Type-I Collagen-Based Skin Substitute and SOC | Active comparator | 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). Receives: Device: High Purity Type-I Collagen-Based Skin Substitute and SOC |
| Acellular Intact Fish Skin Matrix and SOC | Active comparator | 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. Receives: Device: Acellular Intact Fish Skin Matrix and SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 13 (initial closure assessed through Week 12; confirmation visit approximately 7 days later)
Secondary outcomes (8)
Percentage Wound Area Reduction Over Time
Percentage reduction in wound area from baseline, measured by standardized digital photography and central digital planimetry.
Measured: 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.
Measured: Week 12
Time to Confirmed Complete Wound Closure
Time from randomization to confirmed complete closure of the target ulcer, analyzed by Kaplan-Meier methods.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and Week 12
Scar Quality (Vancouver Scar Scale)
Vancouver Scar Scale assessing pigmentation, pliability, height, and vascularity; total score 0-13, lower = better.
Measured: Week 12 or at confirmed closure
Ulcer Recurrence
Recurrence of the index ulcer after confirmed closure, monitored through study completion.
Measured: Up to Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start28 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Sponsor type
- University, hospital or other
- Collaborators
- Mysore Medical College and Research Institute, Mysurur, National Institute of Burn & Plastic Surgery, Dhaka, EKAGRA Health, Dhaka
- Responsible party
- Sponsor
- Investigators
- Prema Dhanraj, MS, MCh, Study chair, Rajarajeshwari Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781917
- Sponsor's protocol ID
- AIMS/IEC/275/2026
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.
PubMed 39649230Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.
PubMed 41122365Lullove EJ, Liden B, Winters C, McEneaney P, Raphael A, Lantis Ii JC. A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers. Wounds. 2021 Jul;33(7):169-177. doi: 10.25270/wnds/2021.169177. Epub 2021 Apr 14.
PubMed 33872197Lantis Ii JC, Lullove EJ, Liden B, McEneaney P, Raphael A, Klein R, Winters C, Huynh RN. Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial. Wounds. 2023 Apr;35(4):71-79. doi: 10.25270/wnds/22094.
PubMed 37023475Dardari D, Piaggesi A, Potier L, Sultan A, Diener H, Francois M, Dorweiler B, Bouillet B, M'Bemba J, Chaillous L, Clerici G, Kessler L, Wetzel-Roth W, Storck M, Davidsson OB, Baldursson B, Kjartansson H, Lantis JC, Charpentier G. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024 Dec;3(12):EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub 2024 Oct 4.
PubMed 39365895Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet. 2025 Apr 14:S0140-6736(25)00672-5. doi: 10.1016/S0140-6736(25)00672-5. Online ahead of print.
PubMed 40245901
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomized, Controlled Clinical Trial Comparing High-Purity Type-I Collagen-Based Skin Substitute Versus Acellular Intact Fish Skin Matrix in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07781917
- Acronym / sponsor ID
- AIMS/IEC/275/2026
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- Diabetic Foot Ulcer;, High Purity Type-I Collagen-Based Skin Substitute;, Acellular Intact Fish Skin Matrix;, Randomized Controlled Clinical Trial;, Multicentric Study;, Dermal Matrix
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G NagaraUniversity, hospital or other
- Collaborators
- Mysore Medical College and Research Institute, Mysurur, National Institute of Burn & Plastic Surgery, Dhaka, EKAGRA Health, Dhaka
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Purity Type-I Collagen-Based Skin Substitute and SOC | Active comparator | Device: High Purity Type-I Collagen-Based Skin Substitute and SOCThe 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). |
| Acellular Intact Fish Skin Matrix and SOC | Active comparator | Device: Acellular Intact Fish Skin Matrix and SOCThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must be at least 18 years of age or older.
- Subjects must have a diagnosis of type 1 or 2 diabetes mellitus.
- Diabetic foot ulcer located below the malleoli, Wagner Grade 1 or 2 (University of Texas Grade 1-2), without exposed bone.
- Target ulcer present for a minimum of 4 weeks, with post-debridement area of approximately 5-20 cm².
- Failure to achieve ≥30% ulcer-area reduction during the run-in period, or an equivalent documented waiver (Section 12.1).
Key exclusion criteria (15 listed)
- A subject known to have a life expectancy of less than 6 months.
- If the target ulcer is infected or if there is cellulitis in the surrounding skin.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence; Wagner Grade ≥3.
- A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Purity Type-I Collagen-Based Skin Substitute and SOCAlso: HPTCArm 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. | Device | High Purity Type-I Collagen-Based Skin Substitute and SOC |
| Acellular Intact Fish Skin Matrix and SOCAlso: AFSM, Decellularized Fish Dermal MatrixArm 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. | Device | Acellular Intact Fish Skin Matrix and SOC |
Primary outcome
Proportion of Participants Achieving Confirmed Complete Wound Closure
Time frame: Up to Week 13 (initial closure assessed through Week 12; confirmation visit approximately 7 days later)
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.
8 secondary outcomes
Percentage Wound Area Reduction Over Time
Time frame: Weeks 2, 4, 6, 8, and 12
Proportion Achieving ≥50%, ≥75%, and ≥90% Wound-Area Reduction
Time frame: Week 12
Time to Confirmed Complete Wound Closure
Time frame: Up to Week 13
Mean Number of Study-Product Applications
Time frame: Up to Week 6
Number of Participants with Adverse Events
Time frame: Up to Week 13
Patient-Reported Quality of Life (DFS-SF)
Time frame: Baseline and Week 12
Scar Quality (Vancouver Scar Scale)
Time frame: Week 12 or at confirmed closure
Ulcer Recurrence
Time frame: Up to Week 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 39649230Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.
- Background: PubMed 41122365Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.
- Background: PubMed 33872197Lullove EJ, Liden B, Winters C, McEneaney P, Raphael A, Lantis Ii JC. A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers. Wounds. 2021 Jul;33(7):169-177. doi: 10.25270/wnds/2021.169177. Epub 2021 Apr 14.
- Background: PubMed 37023475Lantis Ii JC, Lullove EJ, Liden B, McEneaney P, Raphael A, Klein R, Winters C, Huynh RN. Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial. Wounds. 2023 Apr;35(4):71-79. doi: 10.25270/wnds/22094.
- Background: PubMed 39365895Dardari D, Piaggesi A, Potier L, Sultan A, Diener H, Francois M, Dorweiler B, Bouillet B, M'Bemba J, Chaillous L, Clerici G, Kessler L, Wetzel-Roth W, Storck M, Davidsson OB, Baldursson B, Kjartansson H, Lantis JC, Charpentier G. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024 Dec;3(12):EVIDoa2400171. doi: 10.1056/EVIDoa2400171. Epub 2024 Oct 4.
- Background: PubMed 40245901Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet. 2025 Apr 14:S0140-6736(25)00672-5. doi: 10.1016/S0140-6736(25)00672-5. Online ahead of print.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prema Dhanraj, MS, MCh study chair
Rajarajeshwari Medical College and Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Purity Type-I Collagen-Based Skin Substitute and SOC and Acellular Intact Fish Skin Matrix and SOC in people with Diabetic Foot Ulcer (DFU), run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bangladesh, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naveen Narayan (9980023372, naveennumerouno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Confirmed Complete Wound Closure (time frame: Up to Week 13 (initial closure assessed through Week 12; confirmation visit approximately 7 days later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781917, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.