A Randomized Controlled Clinical Trial Comparing High Purity Type-I Collagen-based Skin Substitute to Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers

Adichunchanagiri Institute of Medical Sciences, B G Nagara1 site in 1 country28 target enrollmentJune 3, 2024

ConditionsDiabetic Foot Ulcer (DFU)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcer (DFU)
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Enrollment: 28
Locations: 1
Primary Endpoint: Percentage Wound Area Epithelialization From Week 1 Through 4
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2024

End Date

September 30, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Responsible Party

Principal Investigator

Dr Naveen Narayan MS, MCh (Plastic Surgery)

Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Adichunchanagiri Institute of Medical Sciences, B G Nagara

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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Percentage Wound Area Epithelialization From Week 1 Through 4

Time Frame: 4 weeks

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

Secondary Outcomes

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)