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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vivostat
ClinicalTrials.gov Identifier:
NCT00770939
First received: October 9, 2008
Last updated: October 7, 2011
Last verified: October 2011
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.

Resource links provided by NLM:


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
Study Completion Date: August 2010
Primary Completion Date: May 2010 (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Woundhealing Centre Bispebjerg Hospital
Copenhagen, Denmark, 2400
Germany
Diabetes Klinik Bad Mergentheim GmbH
Bad Mergentheim, Germany
Gesundheitszentrum Mathias Hospital
Rheine, Germany, 48431
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Sweden
Diabetes/ Endokrin sektion
Lund, Sweden
Sponsors and Collaborators
Vivostat
Investigators
Study Director: Michael Ruge Vivostat
  More Information

No publications provided

Responsible Party: Vivostat
ClinicalTrials.gov Identifier: NCT00770939     History of Changes
Other Study ID Numbers: 2007-001
Study First Received: October 9, 2008
Last Updated: October 7, 2011
Health Authority: Germany: Ethics Commission
Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: National Board of Health
Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on October 01, 2014