Efficacy of Human Placental Graft in Diabetic Foot Ulcers
Not Applicable
Terminated
- Conditions
- Diabetic Foot
- Interventions
- Other: Revita Allograft
- Registration Number
- NCT03708029
- Lead Sponsor
- StimLabs
- Brief Summary
To determine the efficacy of full-thickness placental allograft in chronic wound healing
- Detailed Description
To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Male and female patients
- 18-80 years old
- Diagnosis of Type 1 or 2 Diabetes Mellitus
- Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment
- Able to give consent to participate
- Compliance with all aspects of protocol and follow-up
Exclusion Criteria
- Male and female patients younger than 18 years old
- Male or female patients older than 80 years old
- Smoking, and any additional health risk factors contraindicated with Revita use
- Involvement in any other ongoing studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Treatment Revita Allograft Will receive Revita allograft for wound treatment
- Primary Outcome Measures
Name Time Method Complete Wound Closure 12 weeks 100% epithelization
- Secondary Outcome Measures
Name Time Method Percent(%) Healed 12 weeks Percentage of wound healed
Trial Locations
- Locations (3)
Crozer/Keystone Health System, Center for Wound Healing
🇺🇸Springfield, Pennsylvania, United States
Gulf Coast Podiatry
🇺🇸Pensacola, Florida, United States
Louisiana Foot and Ankle Specialists
🇺🇸Lake Charles, Louisiana, United States