Foot Ulcer, Diabetic
Conditions
Brief summary
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.
Detailed description
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.
Interventions
DEVICEPriMatrix
Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
OTHERStandard of Care
Following sharp debridement, moist wound therapy
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women ≥ 18 years of age and able to give their own consent * Type I or Type II diabetes with investigator-confirmed reasonable metabolic control * Study ulcer has a Wagner grade of 1 or 2 * Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement * A full thickness diabetic foot ulcer located on the foot or ankle * An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.
Exclusion criteria
* Suspected or confirmed signs/symptoms of wound infection * Wounds with exposed bone or tendon * Hypersensitivity to bovine collagen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of study ulcers healed | 12 weeks post-randomization | Percent of study ulcers healed at week 12 post-randomization |
Secondary
| Measure | Time frame |
|---|---|
| Cost of Treatment | 12 weeks |
Countries
Puerto Rico, United States
Outcome results
None listed