CTRI/2023/03/050855CompletedPhase 1
A prospective, randomized, assessor-blind, active controlled, multi-center study to demonstrate the safety and efficacy of VELGRAFT, an allogenic cell-based wound dressing, in comparison to standard moist wound dressing in management of chronic diabetic foot ulcers that have attained granulation tissue.
Datt Mediproducts Private Limited4 sites in 1 country24 target enrollmentStarted: March 28, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 4
- Primary Endpoint
- 1. Proportion of participants with complete wound closure at 12 weeks. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements
Study Overview
Brief Summary
A new allogenic cell-based wound dressing is been tested for its safety and efficacy in patients with chronic diabetic foot ulcer that have attained granulation. evaluation of their quality of life after the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Willing and able to provide written informed consent and to comply with the requirements of protocol 2.Subjects ≥ 18 years of age 3.Subjects with type 1 or type 2 diabetes mellitus 4.Subjects with foot ulcer for greater than 4 weeks and less than 54 weeks at the time of screening visit 5.Subject’s foot ulcer located below malleoli and is between 1-20 cm2 (both inclusive) in size on day 1 6.Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days: a.Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR b.ABIs with results of ≥ 0.7 and ≤ 1.2, OR c.Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg 7.Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner’s scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment (refer Appendix- 19.1 and 19.2) 8.Subject is able and willing to wear an off-loading device or orthopedic shoe 9.Subject whose screening laboratory values are within normal range or are considered clinically not significant by the Investigator 10.Female subjects willing to use adequate contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout the study.
Exclusion Criteria
- •1.Subjects with gangrene present on any part of the affected foot 2.Subjects who are hypersensitive to VELGRAFT and its contents 3.Subjects with ulcer of non-diabetic pathophysiology 4.If the subjects ulcer is over a Charcot deformity 5.Subjects with cellulitis, or other evidence of infection 6.Subject is currently being treated with chemotherapeutic agents and corticosteroids 7.Subjects with HbA1c > 10.0% 8.Subjects with positive test for HIV, HBV or HCV 9.Subject with a positive Coronavirus infection (COVID-19) on the basis of RT-PCR of respiratory specimen 10.Known hypersensitivity, contraindication or intolerance to any of the components of the investigational product 11.Subjects had a previous lower extremity amputation.
- •12.Subjects who have received allograft, autograft, xenograft, or cellular therapy within last 30 days of screening visit 13.Female subjects who are nursing, pregnant, or planning on becoming pregnant during the study 14.Subjects with mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol 15.Subject is currently participating or has participated in another clinical study within the past 30 days prior to enrollment 16.Any coexisting serious or uncontrolled comorbid condition that may not make the patient eligible to participate in the study.
Outcomes
Primary Outcomes
1. Proportion of participants with complete wound closure at 12 weeks. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements
Time Frame: 12 weeks
2. Proportion of participants reporting treatment emergent adverse events during the study period
Time Frame: 12 weeks
Secondary Outcomes
- 1. Proportion of participants with complete wound closure by 24 weeks(2. Time to reach complete wound closure)
Investigators
Study Sites (4)
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