Efficacy of Human Placental Graft in Diabetic Foot Ulcers

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03708029

Enrollment

Registered

2018-10-16

Start date

2018-11-13

Completion date

2019-12-01

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

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

Interventions

OTHERRevita Allograft

Human placental allograft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete Wound Closure	12 weeks	100% epithelization

Secondary

Measure	Time frame	Description
Percent(%) Healed	12 weeks	Percentage of wound healed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026