Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Stryker Trauma and Extremities

Status: Completed

Conditions: Diabetic Foot Ulcers

Treatments: Device: APM Graft (BIOTAPE XMTM); Other: Wound Debridement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353495

009-BIO-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

APM Graft (BIOTAPE XMTM

Experimental group

Description:

graft applied to wound q 3 weeks for 12 weeks

Treatment:

Other: Wound Debridement

Device: APM Graft (BIOTAPE XMTM)

standard wound care

Active Comparator group

Description:

Wound debridement and gels and foams applied to wound weekly for 12 weeks.

Treatment:

Other: Wound Debridement