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dHACM In the Treatment of Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EpiFix
Sponsored by
MiMedx Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetes Mellitus, Foot Diseases, Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject with a DFU that meets all of the following requirements:

    • Wound diabetic in origin
    • Located on the dorsal or plantar surface of the foot
    • Size ranging from 1 to 25 cm2 (Debridement will be done prior to measurement and treatment, if clinically indicated)
    • Open a minimum of 30 days prior to treatment (Day 0)
    • 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:

    • Age 18 or older
    • Type 1 or 2 Diabetic (criteria for the diagnosis of diabetes mellitus per ADA)
    • Willing and able to provide consent and participate in all procedures necessary to complete the study
    • 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:

    • Non-Index wounds within 2 cm of the index DFU
    • Active infection at index DFU
    • Index DFU greater than one year in duration without intermittent closure
    • DFU is a possible non-revascularizable surgical site
    • Known or suspected local skin malignancy to the index diabetic ulcer
    • 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®, or other scaffold materials (e.g. Oasis®, MatriStem®) within the last 30 days

  2. Subjects with the following lab values at Day 0:

    • HbA1C ≥ 12% at any time within previous 60 days
    • Serum Creatinine ≥ 3.0mg/dl within last 6 months

  3. Therapy Related Exclusions:

    • Subjects previously or currently enrolled in this study
    • Subjects being treated with investigational drug(s) or investigational therapeutic device(s) within 30 days
    • Subjects currently receiving radiation therapy or chemotherapy
    • Currently being treated with antibiotics

  4. Other Exclusion Criteria:

    • Active Charcot deformity or major structural abnormalities of the foot
    • Known allergy to Gentamicin sulfate or Streptomycin sulfate
    • Subjects diagnosed with autoimmune connective tissue diseases
    • Any pathology that would limit the blood supply and compromise healing
    • Known history of poor compliance with medical treatments
    • Subjects who are known to be pregnant, plan to become pregnant, or are breast feeding

Sites / Locations

  • The Mayer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EpiFix

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to complete closure
As assessed by photographic evaluation and the Investigator
Rate of wound closure
As assessed by photographic evaluation and the Investigator
Incidence of ulcer recurrence
Incidence of ulcer recurrence at the site of the study ulcer
Quality of Life -Health Survey
Change in quality of life metrics as measured by SF-36 Health Survey
Quality of Life- Pain Score
Changes in the patients reported pain scores as measure by the Visual Analog Scale
Cost effectiveness of treatment of dHACM
Measuring the amount of product usage

Full Information

First Posted
September 25, 2015
Last Updated
August 23, 2017
Sponsor
MiMedx Group, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02587104
Brief Title
dHACM In the Treatment of Diabetic Foot Ulcers
Official Title
A Single Center, Prospective, Non-Randomized, Historical Controlled Trial of dHACM In the Treatment of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 plus standard of care. Safety and effectiveness will be monitored throughout the study.
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 plus standard of care until 100% epithelialization is achieved. The subjects will be evaluated for efficacy and safety during the course of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetes Mellitus, Foot Diseases, Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EpiFix
Arm Type
Experimental
Arm Description
Weekly application of EpiFix and standard of care (moist wound therapy and offloading)
Intervention Type
Other
Intervention Name(s)
EpiFix
Intervention Description
Weekly application of EpiFix and standard of care (moist wound therapy and offloading)
Primary Outcome Measure Information:
Title
The percentage of subjects with complete closure of the study ulcer
Description
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
Time Frame
12 weeks
Title
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
Description
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to complete closure
Description
As assessed by photographic evaluation and the Investigator
Time Frame
up to 12 weeks
Title
Rate of wound closure
Description
As assessed by photographic evaluation and the Investigator
Time Frame
up to 12 weeks
Title
Incidence of ulcer recurrence
Description
Incidence of ulcer recurrence at the site of the study ulcer
Time Frame
up to 12 weeks
Title
Quality of Life -Health Survey
Description
Change in quality of life metrics as measured by SF-36 Health Survey
Time Frame
up to 12 weeks
Title
Quality of Life- Pain Score
Description
Changes in the patients reported pain scores as measure by the Visual Analog Scale
Time Frame
up to 12 weeks
Title
Cost effectiveness of treatment of dHACM
Description
Measuring the amount of product usage
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject with a DFU that meets all of the following requirements: Wound diabetic in origin Located on the dorsal or plantar surface of the foot Size ranging from 1 to 25 cm2 (Debridement will be done prior to measurement and treatment, if clinically indicated) Open a minimum of 30 days prior to treatment (Day 0) 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: Age 18 or older Type 1 or 2 Diabetic (criteria for the diagnosis of diabetes mellitus per ADA) Willing and able to provide consent and participate in all procedures necessary to complete the study Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) Exclusion Criteria: DFUs meeting any of the criteria below: Non-Index wounds within 2 cm of the index DFU Active infection at index DFU Index DFU greater than one year in duration without intermittent closure DFU is a possible non-revascularizable surgical site Known or suspected local skin malignancy to the index diabetic ulcer 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®, or other scaffold materials (e.g. Oasis®, MatriStem®) within the last 30 days Subjects with the following lab values at Day 0: HbA1C ≥ 12% at any time within previous 60 days Serum Creatinine ≥ 3.0mg/dl within last 6 months Therapy Related Exclusions: Subjects previously or currently enrolled in this study Subjects being treated with investigational drug(s) or investigational therapeutic device(s) within 30 days Subjects currently receiving radiation therapy or chemotherapy Currently being treated with antibiotics Other Exclusion Criteria: Active Charcot deformity or major structural abnormalities of the foot Known allergy to Gentamicin sulfate or Streptomycin sulfate Subjects diagnosed with autoimmune connective tissue diseases Any pathology that would limit the blood supply and compromise healing Known history of poor compliance with medical treatments Subjects who are known to be pregnant, plan to become pregnant, or are breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Mayer, MD
Organizational Affiliation
The Mayer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mayer Institute
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

dHACM In the Treatment of Diabetic Foot Ulcers

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