Diabetic Foot UlcerNCT01921491
DHACM vs Other Commercially Available Treatments
A study testing Dressing Application and Offloading in people with Diabetic Foot Ulcer, run by MiMedx Group, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs). 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?
- Dressing Application and Offloading
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Sep 2015
- 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
- Patients age 18 or older.
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin and larger than 1 cm2. Note: 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 before enrollment/ randomization, with documented failure of conventional ulcer therapy to heal the wound. A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
- Additional wounds may be present but not within 3 cm of the study wound.
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- Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
- Patient's ulcer must exhibit no clinical signs of infection.
- Serum Creatinine less than 3.0mg/dl within last six months.
- HbA1c less than or equal to 12% within last 90 days.
- 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 tendon, muscle, capsule or 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 25 cm2.
- 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 within the last six months.
- 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 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.
- Patients who are pregnant or breast feeding.
- Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
- Known allergy to Gentamicin or Streptomycin, or to bovine collagen.
- Patients with known hypersensitivity to components of any treatment used in the trial.
- Wounds greater than one year in duration without intermittent healing.
- Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
- Patients taking Cox-2 inhibitors.
- Planned use of Dakin's solution, Mafenide Acetate, Scarlet Red Dressing, Tincoban, Zinc Sulfate, Povidone Iodine solution, Mafenide Acetate, Polymyxin/Nystatin or Chlorhexidine during trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Professional Education and Research Institute, Inc.
Roanoke, Virginia, 24016
St. Johns Outpatient Wound Center
Tulsa, Oklahoma, 74135
About this study
The purpose of this study is to determine whether dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs).
Read the detailed description
This is a prospective, stratified, randomized, controlled, comparative, parallel group, multi-center clinical trial comparing the proportion of ulcers completely healed by use of dehydrated human amnion/chorion membrane (dHACM) placed weekly versus placement of bioengineered skin substitute (BSS) placed weekly, versus standard of care in diabetic patients with a diabetic foot ulcer who have adequate arterial perfusion as defined in section, 2.0 (Patient Eligibility), for wound healing to the affected limb.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dressing Application, Offloading
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dressing ApplicationProcedure or surgery
Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
OffloadingDevice
Provision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Surgical debridement of DFU, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice Offloading. Reassessment weekly at office visit. Receives: Device: Offloading |
| Other Commercially Available Product | Active comparator | Application of commercially available product with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional application of commercially available product will be applied weekly at weeks 2-11. Receives: Procedure: Dressing Application; Device: Offloading |
| dHACM | Experimental | Application of dHACM with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional piece of dHACM will be applied weekly at weeks 2-11. Receives: Procedure: Dressing Application; Device: Offloading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control.
Visitrak Wound Measurement System
Measured: 6 weeks
Secondary outcomes (2)
Proportion of patients achieving 100% epithelialization in dHACM group vs other commercially available product and control.
Visitrak Wound Measurement System
Measured: 12 weeks
Cost effectiveness of each treatment modality.
Cost of product x number of visits
Measured: 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 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completionSep 2015
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 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
- NCT01921491
- Sponsor's protocol ID
- EFDFU005
- Status last verified
- Nov 2020
- First submitted
- 9 Aug 2013
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DHACM vs Other Commercially Available Treatments
- ClinicalTrials.gov ID
- NCT01921491
- Acronym / sponsor ID
- EFDFU005
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 2013 (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 dehydrated human amnion/chorion membrane (dHACM) is more effective than another commercially available product or conservative measures alone when used to treat diabetic foot ulcers (DFUs).
Detailed description
This is a prospective, stratified, randomized, controlled, comparative, parallel group, multi-center clinical trial comparing the proportion of ulcers completely healed by use of dehydrated human amnion/chorion membrane (dHACM) placed weekly versus placement of bioengineered skin substitute (BSS) placed weekly, versus standard of care in diabetic patients with a diabetic foot ulcer who have adequate arterial perfusion as defined in section, 2.0 (Patient Eligibility), for wound healing to the affected limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Device: OffloadingSurgical debridement of DFU, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice Offloading. Reassessment weekly at office visit. |
| Other Commercially Available Product | Active comparator | Procedure: Dressing Application, Device: OffloadingApplication of commercially available product with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional application of commercially available product will be applied weekly at weeks 2-11. |
| dHACM | Experimental | Procedure: Dressing Application, Device: OffloadingApplication of dHACM with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional piece of dHACM will be applied weekly at weeks 2-11. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients age 18 or older.
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin and larger than 1 cm2. Note: 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 before enrollment/ randomization, with documented failure of conventional ulcer therapy to heal the wound. A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
Key exclusion criteria (21 listed)
- Patients presenting with an ulcer probing to tendon, muscle, capsule or 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 25 cm2.
- 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 within the last six months.
- 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 |
|---|---|---|
| Dressing ApplicationApplication of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing. | Procedure or surgery | Other Commercially Available Product, dHACM |
| OffloadingProvision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading. | Device | Other Commercially Available Product, Standard of Care, dHACM |
Primary outcome
Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control.
Time frame: 6 weeks
Visitrak Wound Measurement System
2 secondary outcomes
Proportion of patients achieving 100% epithelialization in dHACM group vs other commercially available product and control.
Time frame: 12 weeks
Cost effectiveness of each treatment modality.
Time frame: 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 4 Nov 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dressing Application and Offloading in people with Diabetic Foot Ulcer, run by MiMedx Group, Inc. at 2 sites 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 21 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of ulcers achieving 100% epithelialization in the dHACM group vs other commercially available product and control. (time frame: 6 weeks). 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 4 Nov 2020.