Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

Integra LifeSciences

Status: Terminated

Conditions: Foot Ulcer, Diabetic

Treatments: Other: Standard of Care Moist Wound Therapy; Device: PriMatrix Moist Wound Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01729286

TEI-007

Details and patient eligibility

About

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

Full description

This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type I or Type II diabetes
• A diabetic foot ulcer located on the foot or ankle at least one square centimeter

Exclusion criteria

• Suspected or confirmed signs/symptoms of wound infection
• Hypersensitivity to bovine collagen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

PriMatrix Moist Wound Therapy

Active Comparator group

Description:

sharp debridement, Primatrix, a dressing regimen that maintains a moist wound healing environment, and offloading

Treatment:

Other: Standard of Care Moist Wound Therapy

Device: PriMatrix Moist Wound Therapy

Standard of Care Moist Wound Therapy

Other group

Description:

sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

Treatment:

Other: Standard of Care Moist Wound Therapy