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

NCT06470087 | Completed Results FDA Device

• 1 other identifier: HPTC101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer (DFU)

Outcome Measures

Primary Outcomes (1)

• Percentage Wound Area Epithelialization From Week 1 Through 4

  Percentage wound area epithelialization from week 1 through 4 measured manually with digital photography. Calculated by using: Percentage Epithelialization=(Epithelialized Area / Total Wound Area)×100

  4 weeks

Secondary Outcomes (2)

• Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period

  4 weeks

• Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure

  4 Weeks

Other Outcomes (3)

• Appearance

  The appearance of thewound was assessed only once i.e at the end of 5th week.

• Structural Stability of the Scar

  The appearance of the woundd was assessed only once i.e. at the end of 5th week.

• Wound Recurrence

  During 1-week follow-up

Study Arms (2)

SOC and Type-I Collagen-based Skin Substitute

OTHER

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)

Device: SOC and Type-I Collagen-based Skin Substitute

SOC and Human Amnion/Chorion Membrane

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)

Other: SOC and Human Amnion/Chorion Membrane

Interventions

SOC and Type-I Collagen-based Skin Substitute 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 Type-I Collagen-based Skin Substitute

SOC and Human Amnion/Chorion Membrane 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)

SOC and Human Amnion/Chorion Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead

Study Sites (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Related Publications (6)

• 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

  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.

  PMID: 36824162 BACKGROUND

• 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.

  PMID: 36104736 BACKGROUND

• 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.

  PMID: 30019528 BACKGROUND

• 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.

  PMID: 33543031 BACKGROUND

• 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.

  PMID: 15644549 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

Small study group. The findings of the study is applicable only to those individuals without any vascular compromise.

Results Point of Contact

• Title: Dr Naveen N
• Organization: Adichunchanagiri Institute of Medical Sciences, BG Nagara

drnaveenn@bgsaims.edu.in

9980023372

Study Officials

• Prema Dhanraj, MS, MCh

  RajaRajeswari Medical College and Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 24, 2024
• Study Start: June 3, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 30, 2024
• Last Updated: November 14, 2025
• Results First Posted: January 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)