dHACM Mesh In the Treatment of Diabetic Foot Ulcers

NCT02589210 | Completed DMC

• 1 other identifier: EFDFU008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and effectiveness will be monitored throughout the study.

Conditions

Diabetic Foot Ulcers

Keywords

Diabetes Mellitus; Foot Disease; Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• The percentage of subjects with complete closure

  The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation

  12 weeks

• The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events

  The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.

  up to12 weeks

Secondary Outcomes (6)

• Time to complete closure

  up to 12 weeks

• Rate of wound closure

  up to 12 weeks

• Incidence of ulcer recurrence

  up to 12 weeks

• Quality of Life-SF 36

  Up to 12 weeks

• Quality of Life -VAS

  Up to 12 weeks

Study Arms (1)

EpiFix Mesh

EXPERIMENTAL

Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading)

Other: EpiFix Mesh

Interventions

EpiFix Mesh OTHER

Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading)

EpiFix Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a DFU that meets all of the following requirements:
• A. Wound diabetic in origin B. Located on the dorsal or plantar surface of the foot C. Size ranging from 1 to 25 cm2 (Debridement will be done prior to measurement and treatment, if clinically indicated) D. Open a minimum of 30 days prior to treatment (Day 0) E. Failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of offloading and moist wound therapy immediately prior to treatment on Day 0)
• Affected limb must demonstrate adequate circulation, as demonstrated by one of the tests listed below (completed \<60 days prior to Day 0)
• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg; or
• ABIs with results of ≥0.7 and ≤1.2; or
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected foot
• General Subject Characteristics:
• A. Age 18 or older B. Type 1 or 2 Diabetic (criteria for the diagnosis of diabetes mellitus per ADA) C. Willing and able to provide consent and participate in all procedures necessary to complete the study D. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

You may not qualify if:

• DFUs meeting any of the criteria below:
• A. Non-Index wounds within 2 cm of the index DFU B. Active infection at index DFU C. Index DFU greater than one year in duration without intermittent closure D. DFU is a possible non-revascularizable surgical site E. Known or suspected local skin malignancy to the index diabetic ulcer F. Index DFU treated with biomedical or topical growth factor within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®), EpiFix® Mesh, EpiFix®, or other scaffold materials (e.g. Oasis®, MatriStem®) within the last 30 days
• Subjects with the following lab values at Day 0:
• A. HbA1C ≥ 12% at any time within previous 60 days B. Serum Creatinine ≥ 3.0mg/dl within last 6 months
• A. Subjects previously or currently enrolled in this study B. Subjects being treated with investigational drug(s) or investigational therapeutic device(s) within 30 days C. Subjects currently receiving radiation therapy or chemotherapy D. Currently being treated with antibiotics
• A. Active Charcot deformity or major structural abnormalities of the foot B. Known allergy to Gentamicin sulfate or Streptomycin sulfate C. Subjects diagnosed with autoimmune connective tissue diseases D. Any pathology that would limit the blood supply and compromise healing E. Known history of poor compliance with medical treatments F. Subjects who are known to be pregnant, plan to become pregnant, or are breast feeding

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Diseases; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Musculoskeletal Diseases

Study Officials

• Charles Zelen, DPM

  Professional Education and Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 28, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

US (1)