Clinical trial NCT01353495: Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Official title: A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: Diabetic Foot Ulcers
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.

Detailed description: The primary objective of this study is time -to - healing with wound size determination at 12 weeks.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria and Population:

* 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).
* Patient's ulcer must exhibit no clinical signs of infection.
* 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.
* 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 triphasicor biphasic at the ankle of affected leg

Exclusion Criteria:

* 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 HgA1c 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
* 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.
* Nonrevascularable surgical sites
* Active infection at site
* Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin
* 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

Primary outcomes:
measure: Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Advanced Foot Care and Clinincal Research Center
state: California
city: Roanoke
country: United States
facility: Professional Education & Research Institute
state: Virginia
Study officials:
affiliation: Advanced Foot Care and Clinincal Research Center
name: Jagpreet Mukker, DPM
role: PRINCIPAL_INVESTIGATOR
References: