Evaluation of the Effect of Vivostat Platelet Rich Fibrin(PRF) in the Treatment of Diabetic Foot Ulcers

Vivostat

Status and phase

Completed

Phase 4

Conditions

Diabetic Foot Ulcers

Treatments

Device: Vivostat PRF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00770939

2007-001

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)
Orthopaedic assessment has been completed to rule out a mechanical source of ulceration
Relative wound area reduction less than 50% from week -3 to week 0 (pre-screening period)
Signed informed consent

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
HbA1c > 12%
Male: Hb < 8 mmol/l (12,9 g/dlFemale: Hb < 7 mmol/l (11,3 g/dl)
Platelet count <140 *109/l
Pregnancy and fertile women not practicing sufficient birth control
Fertile women having a positive pregnancy test week 0 Lactating women
Patients on haemodialysis
History of peripheral vascular repair within 4 weeks prior to study enrollment
Bleeding disorders, haemophilia, sickle cell disease, thrombocytopenia, and leukaemia or blood dyscrasias
Current treatment for malignancy or neoplastic disease or collagen vascular disease
Highly communicable disease or diseases that may limit follow - up (e.g. immunocompromised conditions, hepatitis, active tuberculosis)
Patient has inadequate venous access to draw blood
History of alcohol or drug abuse within the last year prior to randomization
Patient known to have psychological, developmental, physical, emotional or social dis-order or other ailments that may interfere with the study requirements
Patients enrolled in an other clinical trial for wound treatment within 30 days prior to enrollment
Non-compliance in the screening period
Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrollment