Efficacy of Human Placental Graft in Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2019-12-01

Brief Summary

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

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Detailed Description

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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

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Treatment

Will receive Revita allograft for wound treatment

Group Type EXPERIMENTAL

Revita Allograft

Intervention Type OTHER

Human placental allograft

Control

Will receive current standard of care for wound treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Revita Allograft

Human placental allograft

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No