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NCT03708029 Clinical Trial

Efficacy of Human Placental Graft in Diabetic Foot Ulcers

Diabetic Foot Clinical Trial

Official title:
A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03708029
Other study ID # SLRV-POD-WC-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 13, 2018
Est. completion date June 30, 2019

Study information
Verified date November 2018
Source StimLabs
Contact Clinical Research Manager
Phone 4706160997
Email bwilliams@stimlabs.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the efficacy of full-thickness placental allograft in chronic wound healing

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 information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Revita Allograft
Human placental allograft

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
StimLabs

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete Wound Closure 100% epithelization 12 weeks
Secondary Percent(%) Healed Percentage of wound healed 12 weeks
See also
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