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

Diabetic Foot Ulcers Clinical Trial

Official title:

A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770939
• Other study ID #: 2007-001
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: October 7, 2011
• Start date: July 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2011
• Source: Vivostat
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionDenmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: National Board of HealthSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Denmark	Woundhealing Centre Bispebjerg Hospital	Copenhagen
Germany	Diabetes Klinik Bad Mergentheim GmbH	Bad Mergentheim
Germany	Gesundheitszentrum Mathias Hospital	Rheine
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Sweden	Diabetes/ Endokrin sektion	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Vivostat

Countries where clinical trial is conducted

Denmark,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of completely healed ulcers after 12 weeks		12 weeks	No
Primary	Percentage of patients with a 50% reduction of wound area after 4 and 8 weeks		8 weeks	No
Secondary	Granulation rate		12 weeks	No