Diabetic Foot UlcerNCT01552499
Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
A study testing Applications of EpiFix in people with Diabetic Foot Ulcer, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Applications of EpiFix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2012
- 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
- Adult, Older adult
Who may be able to join
- Male or female age 18 or older
- Informed consent must be obtained
- Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks direction, with documented failure of prior treatment to heal the wound.
- Patient's ulcer must exhibit no clinical signs of infection.
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- Patient is of legal consenting age.
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Serum Creatine less then 3.0mg/dl
- HbA1c less than 12%
- Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- 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 leg
Who cannot join
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients whose index diabetic foot ulcers are greater than 25cm2.
- Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days,
- Patients whose serum creatinine levels are 3.0mg/dl or greater.
- Patients with a known history of poor compliance with medical treatments.
- Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
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- Patients who are currently receiving radiation therapy or chemotherapy.
- Patients with known or suspected local skin malignancy to the index diabetic ulcer.
- Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
- Patients diagnosed with autoimmune connective tissues diseases.
- Non-revascularizable surgical sites.
- Active infection at site.
- Any pathology that would limit the blood supply and compromise healing.
- Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
- Patient who are pregnant or breast feeding.
- Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.
- Allergy to Gentamycin or Streptomycin.
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 Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Standard of care, Applications of EpiFix
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Applications of EpiFixOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Not described Receives: Other: Standard of care |
| Treatment | Experimental | Not described Receives: Other: Standard of care; Other: Applications of EpiFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of completely healed ulcers in patients treated with amniotic membrane vs. standard of care
Measured: 12 week
Secondary outcomes (2)
Percent change in wound area
Measured: 4 week
Mean time to complete healing
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 posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles M. Zelen, DPM, Principal investigator, Professional Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552499
- Sponsor's protocol ID
- EFDFU001
- Status last verified
- Aug 2015
- First submitted
- 6 Mar 2012
- Last updated
- 17 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01552499
- Acronym / sponsor ID
- EFDFU001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Mar 2012 (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.
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Standard of care |
| Treatment | Experimental | Other: Standard of care, Other: Applications of EpiFix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female age 18 or older
- Informed consent must be obtained
- Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks direction, with documented failure of prior treatment to heal the wound.
Key exclusion criteria (17 listed)
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients whose index diabetic foot ulcers are greater than 25cm2.
- Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days,
- Patients whose serum creatinine levels are 3.0mg/dl or greater.
- Patients with a known history of poor compliance with medical treatments.
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 |
|---|---|---|
| Standard of care | Other | Control, Treatment |
| Applications of EpiFix | Other | Treatment |
Primary outcome
The proportion of completely healed ulcers in patients treated with amniotic membrane vs. standard of care
Time frame: 12 week
2 secondary outcomes
Percent change in wound area
Time frame: 4 week
Mean time to complete healing
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 17 Aug 2015.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
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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 M. Zelen, DPM principal investigator
Professional Education and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applications of EpiFix in people with Diabetic Foot Ulcer, 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 14 inclusion and 17 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 17 Aug 2015. 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 proportion of completely healed ulcers in patients treated with amniotic membrane vs. standard of care (time frame: 12 week). 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 17 Aug 2015.