Diabetic Foot UlcersNCT02589210
dHACM Mesh In the Treatment of Diabetic Foot Ulcers
A study testing EpiFix Mesh in people with Diabetic Foot Ulcers, run by MiMedx Group, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- EpiFix Mesh
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with a DFU that meets all of the following requirements:
- 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:
- 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)
Who cannot join
- DFUs meeting any of the criteria below:
- 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:
- HbA1C ≥ 12% at any time within previous 60 days B. Serum Creatinine ≥ 3.0mg/dl within last 6 months
- Therapy Related Exclusions:
- 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
- Other Exclusion Criteria:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Professional Education and Research Institute
Roanoke, Virginia, 24016
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- EpiFix Mesh
- Keywords
- Diabetes Mellitus, Foot Disease, Foot Ulcer
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Diseases, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiFix MeshOther
Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading)
| Study group | Role | What they receive |
|---|---|---|
| EpiFix Mesh | Experimental | Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading) Receives: Other: EpiFix Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with complete closure
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
Measured: 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.
Measured: up to12 weeks
Secondary outcomes (6)
Time to complete closure
As assessed by photographic evaluation and the Investigator
Measured: up to 12 weeks
Rate of wound closure
As assessed by photographic evaluation and the Investigator
Measured: up to 12 weeks
Incidence of ulcer recurrence
Incidence of ulcer recurrence at the site of the study ulcer
Measured: up to 12 weeks
Quality of Life-SF 36
Change in quality of life metrics as measured by SF-36 Health Survey
Measured: Up to 12 weeks
Quality of Life -VAS
Change in quality of life metrics as measured by VAS
Measured: 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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Zelen, DPM, Principal investigator, Professional Education and Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589210
- Sponsor's protocol ID
- EFDFU008
- Status last verified
- Aug 2017
- First submitted
- 25 Sep 2015
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Single-Blinded, Non-Randomized, Historical Controlled Trial of dHACM Mesh In the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02589210
- Acronym / sponsor ID
- EFDFU008
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetes Mellitus, Foot Disease, Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EpiFix Mesh | Experimental | Other: EpiFix MeshWeekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject with a DFU that meets all of the following requirements:
- Affected limb must demonstrate adequate circulation, as demonstrated by one of the tests listed below (completed <60 days prior to Day 0)
- General Subject Characteristics:
- 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)
Key exclusion criteria (8 listed)
- DFUs meeting any of the criteria below:
- Subjects with the following lab values at Day 0:
- Therapy Related Exclusions:
- Other Exclusion Criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiFix MeshWeekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading) | Other | EpiFix Mesh |
Primary outcome
The percentage of subjects with complete closure
Time frame: 12 weeks
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
Time frame: up to12 weeks
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
6 secondary outcomes
Time to complete closure
Time frame: up to 12 weeks
Rate of wound closure
Time frame: up to 12 weeks
Incidence of ulcer recurrence
Time frame: up to 12 weeks
Quality of Life-SF 36
Time frame: Up to 12 weeks
Quality of Life -VAS
Time frame: Up to 12 weeks
Cost effectiveness of treatment
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Zelen, DPM principal investigator
Professional Education and Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiFix Mesh in people with Diabetic Foot Ulcers, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with complete closure (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.