Efficacy of Human Placental Graft in Diabetic Foot Ulcers

StimLabs

Status: Terminated

Conditions: Diabetic Foot

Treatments: Other: Revita Allograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT03708029

SLRV-POD-WC-001

Details and patient eligibility

About

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

Full 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

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Intervention Treatment

Experimental group

Description:

Will receive Revita allograft for wound treatment

Treatment:

Other: Revita Allograft

Control

No Intervention group

Description:

Will receive current standard of care for wound treatment