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

Diabetic Foot Ulcers Clinical Trial

Official title:

A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353495
• Other study ID #: 009-BIO-001
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2021
• Source: Wright Medical Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Device:
• APM Graft (BIOTAPE XMTM)
Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.

Other:
• Wound Debridement
Wounds debrided in both arms of study

Locations

Country	Name	City	State
United States	Advanced Foot Care and Clinincal Research Center	Fresno	California
United States	Professional Education & Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Wright Medical Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound	12 Weeks