A Prospective, Multi-center, Randomized, Double-blind, Controlled, Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
Ayu, Inc.
Summary
The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. The Primary goal is to assess the safety of VELGRAFT to treat diabetic foot ulcers as compared to standard of care therapy. Secondary goals include the assessment of efficacy of VELGRAFT for healing diabetic foot ulcers compared to standard of care therapy
Description
This phase I study is a prospective, randomized, double-blind, active controlled study in up to 24 patients. The study will be conducted in 2 parts: Part A will include 12 patients in a dose escalation scheme to identify the maximum tolerated application of VELGRAFT (up to 4 cohorts, with 3 patients in each cohort), and Part B will include 12 or more patients randomized 1:1 between the VELGRAFT (with the number of applications based on Part A) and control arms. If dose escalation stops prior to Cohort 4 in Part A, meaning less than 12 patients are enrolled in Part A, then the number of patient…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years 2. Patient has current diagnosis of type 1 or type 2 diabetes mellitus 3. Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit 4. Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1 5. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days: i. Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle brachial index) with results of ≥0.7 and ≤1.2, OR iii. Doppler arterial wave…
Interventions
- Drugan allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix
VELGRAFT is applied topically. Cells used in VELGRAFT are derived from bone marrow from an FDA-registered establishment. The MSCs in VELGRAFT have been tested for the human leukocyte antigen-2 (HLA-2) marker to minimize rejection due to an immune response by the patient and has undergone a battery of biocompatibility testing. Additionally, cells contained in VELGRAFT are cultured in xenogeneic-free medium, reducing risk of sensitivity to animal products. VELGRAFT is considered a combination product, with both biologic and device constituents
- OtherStandard of Care of Diabetic Foot Ulcers
Standard of Care includes Moist Wound Dressing
Location
- Advanced Foot CarePhoenix, Arizona