dHACM Mesh In the Treatment of Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589210
• Other study ID #: EFDFU008
• Status: Completed
• Phase: N/A
• First received: September 25, 2015
• Last updated: August 23, 2017
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
United States	Professional Education and Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to complete closure	As assessed by photographic evaluation and the Investigator	up to 12 weeks
Secondary	Rate of wound closure	As assessed by photographic evaluation and the Investigator	up to 12 weeks
Secondary	Incidence of ulcer recurrence	Incidence of ulcer recurrence at the site of the study ulcer	up to 12 weeks
Secondary	Quality of Life-SF 36	Change in quality of life metrics as measured by SF-36 Health Survey	Up to 12 weeks
Secondary	Quality of Life -VAS	Change in quality of life metrics as measured by VAS	Up to 12 weeks
Secondary	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