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

A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01729286

Acronym

HEALED

Enrollment

Registered

2012-11-20

Start date

2012-09-30

Completion date

2016-10-31

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ulcer, Diabetic

Brief summary

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.

Detailed 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.

Interventions

DEVICEPriMatrix Moist Wound Therapy

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

OTHERStandard of Care Moist Wound Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Complete wound closure	by 12 weeks

Secondary

Measure	Time frame
Change in predicted medical expenditures between PriMatrix and Standard of Care	over 24 weeks
Change in quality of life measurements between PriMatrix and Standard of Care	between baseline and 24 weeks
Nonserious and serious adverse events	over 24 weeks

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026