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

Not Applicable

Completed

Conditions: Diabetic Foot Ulcer (DFU)

Interventions: Device: SOC and Type-I Collagen-based Skin Substitute
Other: SOC and Human Amnion/Chorion Membrane

Registration Number: NCT06470087

Lead Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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.
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.

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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOC and Type-I Collagen-based Skin Substitute	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)
SOC and Human Amnion/Chorion Membrane	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)

Primary Outcome Measures

Name	Time	Method
Change in Wound Area From Week 1 Through 4	4 weeks	Change in wound area reduction from week 1 through 4 measured manually with digital photography

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period	4 weeks	The proportion of subjects that obtain complete closure over the 4-week treatment period
Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure	4 Weeks	Percenatge of participants undergoing repeat applications of Advanced Skin Substitute \& Human Amnion/Chorion Membrane used to obtain wound closure. Since the participants who underwent repeat applications in both groups had only one repeat application, instead of the mean number of repeat applications we are indicating the percentage of participants having repeat applications in both the groups.