Status:
COMPLETED
DHACM vs Other Commercially Available Treatments
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 use...
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 amni...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01921491
Start Date
August 1 2013
End Date
September 1 2015
Last Update
November 4 2020
Active Locations (2)
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1
St. Johns Outpatient Wound Center
Tulsa, Oklahoma, United States, 74135
2
Professional Education and Research Institute, Inc.
Roanoke, Virginia, United States, 24016