NCT00770939
Completed
Phase 4
A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.
Vivostat5 sites in 3 countries60 target enrollmentStarted: July 2008Last updated:
ConditionsDiabetic Foot Ulcers
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Vivostat
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Proportion of completely healed ulcers after 12 weeks
Overview
Brief Summary
Diabetic foot ulcers are a challenge to health care professionals because there are only few effective topical therapeutic interventions.
Growth factor treatment has shown to be beneficial for healing of diabetic foot ulcers in conjunction with extensive surgical debridement. Autologues platelet releasate which contains platelet derived growth factor appears to be more effective than standard therapy in case studies.
This protocol will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot ulcers to identify responders and to enable sample size calculation for a subsequent pivotal trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 4 weeks history (with wound area measurements) within a wound care institution before the first visit (week -3). In case of referral the patient history must be documented
- •All patients must complete a 3 week screening period i.e. they will be interviewed and accessed at the first meeting. During the 3 week period patient compliance will be monitored.
- •Age \>18 years
- •Type I or Type II Diabetes Mellitus
- •Ulcer at or below the ankle which has been present for at least 4 weeks, and has received best practice care
- •Ulcer area between 0,5 and 16 cm2
- •If there is more than one ulcer or bilateral ulcers, the investigator shall choose the one index ulcer to be treated (typically the largest one). The other ulcers will receive standard care and is not included in the study
- •Ulcer type: University of Texas grade IA.
- •Evidence of adequate arterial perfusion: Toe pressure reading of ≥ 30 mmHg or if toe is missing, transcutaneous oxygen (TcPO2) of ≥ 30mmHg on the foot.
- •Patient foot is appropriately off loaded (contact cast, pneumatic walking cast)
Exclusion Criteria
- •Clear indication for surgery (vascular reconstruction or skin transplant)
- •Ulcer with exposed bone or tendon
- •Bone involvement (probe to bone or x-ray)
- •Patients with 3 ulcers or more at the foot investigated
- •Osteomyelitis
- •Clinical signs of infections
- •Necrosis in the wound (one week into the screening period).
- •Patients with known MRSA
- •Malnutrition. Albumin \< 2,5g/dl
- •Ulcers resulting from electrical, chemical, radiation burns
Outcomes
Primary Outcomes
Proportion of completely healed ulcers after 12 weeks
Time Frame: 12 weeks
Percentage of patients with a 50% reduction of wound area after 4 and 8 weeks
Time Frame: 8 weeks
Secondary Outcomes
- Granulation rate(12 weeks)
Investigators
Study Sites (5)
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