Diabetic Foot Clinical Trial
Official title:
A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
To determine the efficacy of full-thickness placental allograft in chronic wound healing
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Louisiana Foot and Ankle Specialists | Lake Charles | Louisiana |
United States | Gulf Coast Podiatry | Pensacola | Florida |
United States | Springfield Hospital - Center for Wound Healing | Springfield | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
StimLabs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Wound Closure | 100% epithelization | 12 weeks | |
Secondary | Percent(%) Healed | Percentage of wound healed | 12 weeks |
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