High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs

NCT ID: NCT06470087

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2024-09-30

Brief Summary

This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.

Detailed Description

The purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human Amnion/Chorion Membrane in the other half.

Conditions

Diabetic Foot Ulcer (DFU)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOC and Type-I Collagen-based Skin Substitute

Arm 1 -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 (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)

Group Type: OTHER

SOC and Type-I Collagen-based Skin Substitute

Intervention Type: DEVICE

Arm 1 -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 (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)

SOC and Human Amnion/Chorion Membrane

Arm 2: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)

Group Type: OTHER

SOC and Human Amnion/Chorion Membrane

Intervention Type: OTHER

Arm 2: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)

Interventions

SOC and Type-I Collagen-based Skin Substitute

Arm 1 -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 (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)

Intervention Type: DEVICE

SOC and Human Amnion/Chorion Membrane

Arm 2: 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 paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap (Crepe Bandage)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects must be at least 18 years of age or older.
• Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
• At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 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 with at least 50% of the ulcer below the malleolus.
• The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
• Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:

• Transcutaneous Oxygen Measurement (TCOM) ≥30 mmHg
• Ankle-Brachial Index (ABI) between 0.7 and 1.3
• Peripheral Vascular Resistance (PVR): Biphasic
• Toe-Brachial Index (TBI) ˃0.6
• 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.

Exclusion Criteria

• 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.

• 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.
• 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 a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
• A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.

o 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adichunchanagiri Institute of Medical Sciences, B G Nagara

OTHER

Sponsor Role: lead

Responsible Party

Dr Naveen Narayan MS, MCh (Plastic Surgery)

Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prema Dhanraj, MS, MCh

Role: STUDY_CHAIR

RajaRajeswari Medical College and Hospital

Locations

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India

Countries

India

References

Dhanraj P, Naveen N, Babu KR, Mahesh MS, Hanumanthaiah KS. Healicoll: An alternate to flap cover for bare bones and tendons. Acta Medica International. 2016 Jan 1;3(1):146-50

Reference Type: BACKGROUND

Wolfe EM, Mathis SA, de la Olivo Munoz N, Ovadia SA, Panthaki ZJ. Comparison of human amniotic membrane and collagen nerve wraps around sciatic nerve reverse autografts in a rat model. Biomater Biosyst. 2022 Apr 7;6:100048. doi: 10.1016/j.bbiosy.2022.100048. eCollection 2022 Jun.

Reference Type: BACKGROUND

PMID: 36824162 (View on PubMed)

Mohammed YA, Farouk HK, Gbreel MI, Ali AM, Salah AA, Nourelden AZ, Gawad MMA. Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis. J Foot Ankle Res. 2022 Sep 14;15(1):71. doi: 10.1186/s13047-022-00575-y.

Reference Type: BACKGROUND

PMID: 36104736 (View on PubMed)

DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Jacobs AM, Zelen CM. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. 2018 Dec;15(6):950-957. doi: 10.1111/iwj.12954. Epub 2018 Jul 17.

Reference Type: BACKGROUND

PMID: 30019528 (View on PubMed)

Huang Y, Kyriakides TR. The role of extracellular matrix in the pathophysiology of diabetic wounds. Matrix Biol Plus. 2020 Apr 22;6-7:100037. doi: 10.1016/j.mbplus.2020.100037. eCollection 2020 May.

Reference Type: BACKGROUND

PMID: 33543031 (View on PubMed)

Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.

Reference Type: BACKGROUND

PMID: 15644549 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HPTC101

Identifier Type: -

Identifier Source: org_study_id