Venous Leg UlcersNCT06831760

A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers

A study testing SOC and Type-I Collagen-based Skin Substitute and SOC and Human Amnion/Chorion Membrane in people with Venous Leg Ulcers, run by Dr Naveen Narayan MS, MCh (Plastic Surgery) at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Venous leg ulcers are chronic wounds caused by venous insufficiency, leading to significant morbidity. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I Collagen-based Skin Substitute (HPTC) vs. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Venous Leg Ulcers
What is being tested?: SOC and Type-I Collagen-based Skin Substitute and SOC and Human Amnion/Chorion Membrane
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteIndia
Study dates: 1 Feb 2025to 10 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 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 a venous leg ulcer (confirmed by clinical and duplex ultrasound evaluation).
At enrolment subjects must have a target VLU with a minimum surface area of 2.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement using a ruler to measure wound area.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
The target ulcer must be located on the foot, ankle and lower leg region.
The target ulcer must be full thickness on the foot or ankle that does not probe to bone.

Show all 13Show fewer

Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
TCOM ≥30 mmHg ii. ABI between 0.7 and 1.3 iii. PVR: Biphasic iv. TBI ˃0.6 v. As an alternative arterial, Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
The subject must consent to using the prescribed off-loading method for the duration of the study.
The subject must agree to attend the twice-weekly/weekly 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 IRB approved ICF before screening procedures are undertaken.

Who cannot join

A subject known to have a life expectancy of <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.
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.

Show all 17Show fewer

A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
A subject with autoimmune or connective tissue disorders.
A subject with malignant wounds or non-venous ulcers.
A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
Women who are pregnant or considering becoming pregnant within the next 6 months and those who are breast feeding.
A subject with end stage renal disease requiring dialysis.
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.
History of autoimmune disease, malignancy, or uncontrolled diabetes (HbA1c >10%).
Allergy to components of High Purity Type-I Collagen-based Skin Substitute or Dehydrated Human Amnion/Chorion Membrane.

Trial locations and contacts

1 site in 1 country.

India1 site

Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448

Other trials in India

About this study

Official title: A Randomized, Controlled Clinical Trial Evaluating the Efficacy of Type-I Collagen-based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers

Read the detailed description

Venous leg ulcers (VLUs) are chronic wounds caused by venous insufficiency, leading to significant morbidity. Current treatment options often include compression therapy, wound debridement, and advanced dressings. Despite advances in wound care, effective treatment remains challenging. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in the treatment of VLUs and to compare the efficacy of these two advanced wound care modalities in accelerating VLU healing.

Conditions: Venous Leg Ulcers
Being tested: SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
Keywords: venous leg ulcer, chronic leg ulcer, leg ulcer, skin substitute, high purity type-I collagen, dehydrated human amnion / chorion membrane
Medical subject headings: Varicose Ulcer, Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOC and Type-I Collagen-based Skin SubstituteDevice
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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap
SOC and Human Amnion/Chorion MembraneDevice
The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap

Study groups in NCT06831760
Study group	Role	What they receive
SOC and Type-I Collagen-based Skin Substitute	Other	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 Receives: Device: SOC and Type-I Collagen-based Skin Substitute
SOC and Human Amnion/Chorion Membrane	Other	The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing Receives: Device: SOC and Human Amnion/Chorion Membrane

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Wound Area Change
Percentage wound area change from week 1 through week 7 measured manually with digital photography
Measured: 7 Weeks
Histopathological Parameters - Vascular Infiltration
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H\&E) for general morphology.
Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (<5 vessels/hpf)
1. Mild infiltration (5-10 vessels/hpf)
2. Moderate infiltration (11-20 vessels/hpf)
3. Abundant infiltration (>20 vessels/hpf) (0-worse; 3-better)
Measured: 5 days
Histopathological Parameters - Neo-epithelialization
Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H\&E) for general morphology.
Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration
1. Minimal migration (<25% wound coverage)
2. Moderate migration (25-75% coverage)
3. Extensive migration (>75% coverage) (0-worse; 3-better)
Measured: 5 days
Histopathological Parameters - Fibroblast Activity
Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity.
Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts
1. Moderate cellularity, minimal matrix production
2. High cellularity, active-matrix synthesis
3. Very high activity with extensive matrix deposition (0-worse; 3-better)
Measured: 5 Days
Histopathological Parameters - Capillary Density
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia.
Serial sections of 4μm thickness were prepared and stained with: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue
Measured: 5 days
Histopathological Parameters - Inflammatory Response
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia.
Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H\&E) for general morphology Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate
1. Mild chronic inflammation
2. Moderate mixed inflammation
3. Severe acute inflammation (0-worse; 3-better)
Measured: 5 days
Histopathological Parameters - Collagen Deposition
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia.
Serial sections of 4μm thickness were prepared and stained with: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix
1. Loose, immature collagen
2. Moderate organized collagen
3. Dense, mature collagen architecture (0-worse; 3-better)
Measured: 5 days

Secondary outcomes (4)

Time to Achieve Complete Wound Closure
The time to achieve complete wound closure of the target ulcer by the end of 7 weeks
Measured: 7 weeks
Percentage of Subjects to Obtain Complete Closure
The percentage of subjects that obtain complete closure over the 7 week treatment period
Measured: 7 Weeks
Number of Patients Requiring Repeated Application
Number of patients requiring repeated applications of the Advanced Skin Substitute \& Human Amnion/Chorion Membrane used to obtain wound closure
Measured: 6 Weeks
Intervention Related Adverse Events
Number of participants with intervention related adverse events related to the intervention (e.g., infection, allergic reactions)
Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202510 Jul 2025

First posted18 Feb 2025
Study start1 Feb 2025
Primary completion30 Jun 2025
Study completion10 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Venous Leg UlcersStudies 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: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06831760
Sponsor's protocol ID: AIMS/IEC/004/2025
Status last verified: Sep 2025
First submitted: 27 Jan 2025
Last updated: 22 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Bianchi C, Cazzell S, Vayser D, Reyzelman AM, Dosluoglu H, Tovmassian G; EpiFix VLU Study Group. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(R) ) allograft for the treatment of venous leg ulcers. Int Wound J. 2018 Feb;15(1):114-122. doi: 10.1111/iwj.12843. Epub 2017 Oct 11.
PubMed 29024419
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 39649230
Serena TE, Carter MJ, Le LT, Sabo MJ, DiMarco DT; EpiFix VLU Study Group. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014 Nov-Dec;22(6):688-93. doi: 10.1111/wrr.12227. Epub 2015 Jan 8.
PubMed 25224019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Venous Leg Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Clinical Trial Evaluating the Efficacy of Type-I Collagen-based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers
ClinicalTrials.gov ID: NCT06831760
Acronym / sponsor ID: AIMS/IEC/004/2025
Conditions: Venous Leg Ulcers
Keywords: venous leg ulcer, chronic leg ulcer, leg ulcer, skin substitute, high purity type-I collagen, dehydrated human amnion / chorion membrane
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Dr Naveen Narayan MS, MCh (Plastic Surgery)University, hospital or other
Study start: 1 Feb 2025 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 10 Jul 2025 (actual)
First posted: 18 Feb 2025 (actual)
Results: Posted 22 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SOC and Type-I Collagen-based Skin Substitute	Other	Device: SOC and Type-I Collagen-based Skin SubstituteThe 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
SOC and Human Amnion/Chorion Membrane	Other	Device: SOC and Human Amnion/Chorion MembraneThe SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of a venous leg ulcer (confirmed by clinical and duplex ultrasound evaluation).
At enrolment subjects must have a target VLU with a minimum surface area of 2.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement using a ruler to measure wound area.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
The target ulcer must be located on the foot, ankle and lower leg region.

Key exclusion criteria (17 listed)

A subject known to have a life expectancy of <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.
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
SOC and Type-I Collagen-based Skin SubstituteThe 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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Device	SOC and Type-I Collagen-based Skin Substitute
SOC and Human Amnion/Chorion MembraneThe SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap	Device	SOC and Human Amnion/Chorion Membrane

Primary outcome

Percentage Wound Area Change
Time frame: 7 Weeks
Percentage wound area change from week 1 through week 7 measured manually with digital photography
Histopathological Parameters - Vascular Infiltration
Time frame: 5 days
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H\&E) for general morphology. Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (<5 vessels/hpf) 1. Mild infiltration (5-10 vessels/hpf) 2. Moderate infiltration (11-20 vessels/hpf) 3. Abundant infiltration (>20 vessels/hpf) (0-worse; 3-better)
Histopathological Parameters - Neo-epithelialization
Time frame: 5 days
Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H\&E) for general morphology. Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration 1. Minimal migration (<25% wound coverage) 2. Moderate migration (25-75% coverage) 3. Extensive migration (>75% coverage) (0-worse; 3-better)
Histopathological Parameters - Fibroblast Activity
Time frame: 5 Days
Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity. Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts 1. Moderate cellularity, minimal matrix production 2. High cellularity, active-matrix synthesis 3. Very high activity with extensive matrix deposition (0-worse; 3-better)
Histopathological Parameters - Capillary Density
Time frame: 5 days
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue
Histopathological Parameters - Inflammatory Response
Time frame: 5 days
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H\&E) for general morphology Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate 1. Mild chronic inflammation 2. Moderate mixed inflammation 3. Severe acute inflammation (0-worse; 3-better)
Histopathological Parameters - Collagen Deposition
Time frame: 5 days
Histopathological Assessment - Before application and on the 5th day post-application of either HPTC or dHCAM, a 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix 1. Loose, immature collagen 2. Moderate organized collagen 3. Dense, mature collagen architecture (0-worse; 3-better)

4 secondary outcomes

Time to Achieve Complete Wound Closure
Time frame: 7 weeks
Percentage of Subjects to Obtain Complete Closure
Time frame: 7 Weeks
Number of Patients Requiring Repeated Application
Time frame: 6 Weeks
Intervention Related Adverse Events
Time frame: 6 Weeks

Results and safety

Results posted to the registry on 22 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SOC and Type-I Collagen-based Skin Substitute	30	30
SOC and Human Amnion/Chorion Membrane	30	30

Primary outcome: Percentage Wound Area Change

Time frame: 7 Weeks. Mean (Standard Deviation). Unit: percentage wound area reduction

Measure	SOC and Type-I Collagen-based Skin Substitute n = 30	SOC and Human Amnion/Chorion Membrane n = 30
Value	78.9 (17.8)	65.4 (7.9)

Primary outcome: Histopathological Parameters - Vascular Infiltration

Time frame: 5 days. Mean (Standard Deviation). Unit: score on a scale (0-worse; 3-better)

Measure	SOC and Type-I Collagen-based Skin Substitute n = 30	SOC and Human Amnion/Chorion Membrane n = 30
Value	2.73 (0.45)	1.87 (0.68)

Primary outcome: Histopathological Parameters - Neo-epithelialization

Time frame: 5 days. Mean (Standard Deviation). Unit: score on a scale (0-worse; 3-better)

Measure	SOC and Type-I Collagen-based Skin Substitute n = 30	SOC and Human Amnion/Chorion Membrane n = 30
Value	2.67 (0.48)	1.63 (0.72)

Primary outcome: Histopathological Parameters - Fibroblast Activity

Time frame: 5 Days. Mean (Standard Deviation). Unit: score on a scale (0-worse; 3-better)

Measure	SOC and Type-I Collagen-based Skin Substitute n = 30	SOC and Human Amnion/Chorion Membrane n = 30
Value	2.80 (0.41)	1.93 (0.64)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 Weeks including 1 week follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOC and Type-I Collagen-based Skin Substitute	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30
SOC and Human Amnion/Chorion Membrane	0 of 30 (0%)	3 of 30 (10%)	0 of 30

Limitations and caveats (from the sponsor): Single-centre design may limit generalizability to other healthcare settings and populations. Relatively short follow-up period (7 weeks), while sufficient for assessing acute healing outcomes, may not capture long-term outcomes, recurrence rates or durability of treatment effects. T Study was not completely blinded due to the nature of the interventions Study included a specific range of wound sizes and may not be generalizable to very large wounds.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29024419Bianchi C, Cazzell S, Vayser D, Reyzelman AM, Dosluoglu H, Tovmassian G; EpiFix VLU Study Group. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(R) ) allograft for the treatment of venous leg ulcers. Int Wound J. 2018 Feb;15(1):114-122. doi: 10.1111/iwj.12843. Epub 2017 Oct 11.
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 25224019Serena TE, Carter MJ, Le LT, Sabo MJ, DiMarco DT; EpiFix VLU Study Group. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014 Nov-Dec;22(6):688-93. doi: 10.1111/wrr.12227. Epub 2015 Jan 8.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Prema Dhanraj, MS, MCh study chair

Rajarajeshwari Medical College and Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 17 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Wound Area Change (time frame: 7 Weeks). The study lists 7 primary outcomes in all. 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 NCT06831760, which also lists 3 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 22 Sep 2025.