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

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ClinicalTrials.gov Identifier: NCT00770939
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Vivostat

Tracking Information
First Submitted Date  ICMJE October 9, 2008
First Posted Date  ICMJE October 10, 2008
Last Update Posted Date October 12, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00770939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Granulation rate [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of Vivostat Platelet Rich Fibrin(PRF) in the Treatment of Diabetic Foot Ulcers
Official Title  ICMJE A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcers
Intervention  ICMJE Device: Vivostat PRF
Ulcer will be treated week 1,2,3,4,5 and 6 with Vivostat PRF
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Germany,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00770939
Other Study ID Numbers  ICMJE 2007-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vivostat
Study Sponsor  ICMJE Vivostat
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Ruge Vivostat
PRS Account Vivostat
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP