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Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

NCT02399826 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-08-16

No results posted yet for this study

Summary

This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period

Conditions

  • Diabetic Foot
  • Foot Ulcer; Diabetic

Interventions

DEVICE

Offloading

Provision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement

PROCEDURE

Dressing Application

Application of a non adherent dressing, and a multi-layer compression dressing

Sponsors & Collaborators

  • Musculoskeletal Transplant Foundation

    collaborator OTHER

  • Lower Extremity Institute for Research and Therapy

    lead OTHER

Principal Investigators

  • Lawrence Didomenico, DPM · medical director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02399826 on ClinicalTrials.gov