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

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Completed

Conditions: Diabetic Foot Ulcer (DFU)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06470087

HPTC101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

SOC and Type-I Collagen-based Skin Substitute

Other group

Description:

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)

Treatment:

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

SOC and Human Amnion/Chorion Membrane

Other group

Description:

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)

Treatment:

Other: SOC and Human Amnion/Chorion Membrane