dHACM Mesh In the Treatment of Diabetic Foot Ulcers

A Single Center, Prospective, Single-Blinded, Non-Randomized, Historical Controlled Trial of dHACM Mesh In the Treatment of Diabetic Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Other: EpiFix Mesh

Detailed Description

Approximately 20 subjects will be enrolled in this study. Subjects will be seen for up to12 weeks unless 100% epithelialization of the index wound and two subsequent healing confirmation visits have been achieved prior to week 12. Each subject will receive a weekly application of the EpiFix Mesh plus standard of care until 100% epithelialization is achieved. The subjects will be evaluated for efficacy and safety during the course of the trial.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Professional Education and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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)

2. 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
3. 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)

Exclusion Criteria:

1. 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

2. 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

3. Therapy Related Exclusions:

   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

4. Other Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EpiFix Mesh; Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading)	Other: EpiFix Mesh; Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete closure	As assessed by photographic evaluation and the Investigator	up to 12 weeks
Rate of wound closure	As assessed by photographic evaluation and the Investigator	up to 12 weeks
Incidence of ulcer recurrence	Incidence of ulcer recurrence at the site of the study ulcer	up to 12 weeks
Quality of Life-SF 36	Change in quality of life metrics as measured by SF-36 Health Survey	Up to 12 weeks
Quality of Life -VAS	Change in quality of life metrics as measured by VAS	Up to 12 weeks
Cost effectiveness of treatment	Cost effectiveness of treatment regiment. Capturing how much tissue is used, how often it is applies, the size used at each visit and how much is wasted.	up to 12 weeks

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Principal Investigator: Charles Zelen, DPM, Professional Education and Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Foot Ulcer; Foot Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: EFDFU008