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
Age ≥ 18 years
Patient has current diagnosis of type 1 or type 2 diabetes mellitus
Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
Gangrene is present on any part of the affected foot
Ulcer is of non-diabetic pathophysiology
Patient's ulcer is over a Charcot deformity
Ulcer total surface area > 20 cm2
Sequential
an 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
DrugVELGRAFT 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
Standard of Care of Diabetic Foot Ulcers
Other interventionStandard of Care includes Moist Wound Dressing
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess the safety of VELGRAFT to treat DFUs as compared to standard of care therapy through the difference between the VELGRAFT IP and the control groups for all treated patients in the proportion of patients reporting adverse events during the active study period. The investigator will assess the relationship between study therapy and the occurence of each AE/SAE and will use clinical judgment to determine if there is a reasonable possibility that the IP was responsible for the AE/SAE being reported. Determination of relatedness to the IP will be defined according to one of the following categories: * Definite - The AE/SAE is clearly related to the IP * Probable - The AE/SAE is likely related to the IP * Possible - The AE/SAE may be related to the IP * Unlikely - The AE/SAE is doubtfully related to the IP * Unrelated - The AE/SAE is clearly NOT related to the IP AE/SAE's will be assessed by CTCAE Version 5.0 and safety data of the study will be evaluated by an independent DSMB.
Efficacy of VELGRAFT
To assess the efficacy of VELGRAFT for healing DFUs compared to standard of care therapy. This will be assessed by the difference between the two treatment arms in the proportion of participants with complete wound closure at week 12 and 14. Complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits, Week 12 and 14. Wounds will be measured by Imito Wound Measurement Software.
Wound Closure Rate
To Evaluate wound closure rate over the course of the trial. This will be measured by the proportion of participants with complete wound closure by 24 weeks.
Ulcer Recurrence Rate
To measure ulcer recurrence rate over the course of the trial
Assess Re-epithelialization
to Assess Re-epithelialization over the course of the Trial
