Diabetic Foot Ulcers
Conditions
Keywords
non-healing wound, diabetic foot ulcer, platelet rich plasma
Brief summary
A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.
Detailed description
This is a prospective, randomized, single-blind, controlled, multi-center study for subjects undergoing DFU treatment. Qualified subjects will be randomized (1:1); test group (PRP Concepts Fibrin Bio-Matrix) and control group (usual and customary practice). The study will consist of 3 periods: a screening period, an active treatment period, and a follow-up period (if healed). Approximately 250 subjects will be enrolled. Subjects will be ≥18 years of age with a chronic Wagner grade 1 or 2 DFU (greater than 1 month duration). Each subject will be enrolled in the active treatment period for up to 12 weeks, or to closure of wound with a confirmatory visit 2 weeks after wound closure, whether such closure occurs at 12 weeks or earlier.
Interventions
Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
Usual and customary care for non-healing wounds
Sponsors
PRP Concepts, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medicare eligible * A full thickness diabetic foot ulcer with a viable wound bed * Diabetes mellitus (type I or II) that is adequately controlled * The ulcer is greater than 4 weeks duration. * The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 DFU (see Appendix for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel). * Post-debridement, the ulcer size must be between 0.5 - 20 cm2. * One of the following assessments was completed to confirm pedal circulation: ankle / brachial index is between 0.7 to 1.2; transcutaneous partial pressure oxygen (TcPO2) \> 30 mmHg at the ankle; or toe pressure of \>40mm Hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) * Able and willing to provide a voluntary written informed consent. * Able and willing to wear an off-loading device or orthopedic shoe * Able and willing to attend scheduled follow-up visits and study related exams
Exclusion criteria
* Greater than 30% reduction in wound size during the first two weeks of observation and treatment by the investigator * Wagner 3, 4, 5 DFU * Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis * Wounds that are likely to require dressing changes more frequent than twice weekly (heavy exudates). * Known allergy tor sensitivity to Eclipse PRP kit components (calcium chloride, calcium gluconate or acid citrate dextrose solution A (ACDA)) * Presence of Gangrene * Active Charcot's disease as determined by clinical and radiographic examination of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers) * Malignancy at or near the ulcer site * Known serum albumin \< 2.5 mg/dl, Known renal failure as determined by a Creatinine \> 2.5 mg/dl, Plasma Platelet count of less than 100 x 109/L, Hemoglobin of less than 10.5 g/dL * Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV * Severe liver disease. Severe liver disease is defined as known history of chronic hepatitis or cirrhosis &/or the following abnormal Liver Function Tests: ALT & AST \>35, ALP \>120, PT \>12 seconds. * Presence of additional abnormal lab values obtained within 7 days prior to the Day 0 visit determined to be clinically significant by the investigator including: WBC \>13,000/cm3 or \< 5, 000 cm3, or electrolytes that are outside the host institution's range of normal. * Radiation therapy, chemotherapy, chronic steroid use or immunosuppressive therapy within 30 days of enrollment * Received another investigational device or drug within 30 days of enrollment * Received allograft, autograft or xenograft within 30 days of enrollment * Subject has inadequate venous access for repeated blood draw required for Eclipse RPR administrations * Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area. * Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT) * Any condition judged by the investigator that would cause the study to be detrimental to the subject * Alcohol or drug abuse, defined as current medical treatment for substance abuse * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound closure | 12 weeks | Complete wound closure is defined as full epithelialization of the wound with the absence of drainage, durability confirmed at 2 weeks |
| Percent of wounds healed | 12 weeks | Percentage of closure of the wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Trajectory | 4, 8, 12 weeks | Mean of percent (%) wound size changes at 4 weeks, 8 weeks and 12 weeks |
| Ulcer Recurrence | 3 months | Ulcer recurrence out to 3 months for subjects whose wounds heal by conclusion of 12 week visit. |
| Quality of Life score | 3 months | Changes in Quality of Life scores and ability to return to previous function/resumption of normal activities |
Countries
United States
Contacts
Primary ContactDamon Keeley
Backup ContactNigel Gladhart
Outcome results
None listed