Evaluation of the Effect of Vivostat Platelet Rich Fibr...

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

Evaluation of the Effect of Vivostat Platelet Rich Fibrin(PRF) in the Treatment of Diabetic Foot Ulcers
October 2008
clincaltrials.gov

This study is currently recruiting participants.
Verified by Vivostat, October 2008

Sponsored by: Vivostat
Information provided by: Vivostat
ClinicalTrials.gov Identifier: NCT00770939
Purpose

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.

Condition Intervention Phase
Diabetic Foot Ulcers
Device: Vivostat PRF
Phase IV

MedlinePlus related topics: Diabetic Foot Foot Health

Drug Information available for: Fibrin

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.

Further study details as provided by Vivostat:

Primary Outcome Measures:

* Proportion of completely healed ulcers after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
* Percentage of patients with a 50% reduction of wound area after 4 and 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Granulation rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Device: Vivostat PRF
Ulcer will be treated week 1,2,3,4,5 and 6 with Vivostat PRF

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

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 moni-tored.
* Age >18 years
* Type I or Type II Diabetes Mellitus
* Plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care
* Ulcer area between 1 and 10 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 stan-dard 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 ul-ceration
* 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
* 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 g/dl Female : Hb < 7 g/dl
* Platelet count <140 *109/l
* Pregnancy and fertile women not practising sufficient birth control
* Lactating women
* Patients on haemodialysis
* History of peripheral vascular repair within 4 weeks prior to randomization
* 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. immuno-compromised 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 en-rolment
* Non-compliance in the screening period
* Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrolment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770939

Contacts
Contact: Jan Apelqvist, MD +46705161664

Locations
Denmark
Woundhealing Centre Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Bo Joergensen, MD +45 35313531 bj05@bbh.regionh.dk
Principal Investigator: Bo Joergensen, MD

Sponsors and Collaborators
Vivostat

Investigators
Study Director: Pia Norup Nielsen, MD Vivostat
More Information


Responsible Party: Vivostat A/S ( CEO Tom Bjerg Lauritzen )
Study ID Numbers: 2007-001
First Received: October 9, 2008
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00770939
Health Authority: Germany: Ethics Commission; Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by Vivostat:
Complete healing of chronic diabetic foot ulcers
Platelet Rich Fibrin
Vivostat
Growth factor treatment
Treatment of chronic diabetic foot ulcers

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer