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

NCT00770939 | Completed Phase 4

• 1 other identifier: 2007-001
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 5

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.

Conditions

Diabetic Foot Ulcers

Keywords

Complete healing of chronic diabetic foot ulcers; Platelet Rich Fibrin; Vivostat; Growth factor treatment; Treatment of chronic diabetic foot ulcers

Outcome Measures

Primary Outcomes (2)

• Proportion of completely healed ulcers after 12 weeks

  12 weeks

• Percentage of patients with a 50% reduction of wound area after 4 and 8 weeks

  8 weeks

Secondary Outcomes (1)

• Granulation rate

  12 weeks

Interventions

Vivostat PRF DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivostat: lead

Study Sites (5)

Woundhealing Centre Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Diabetes Klinik Bad Mergentheim GmbH

Bad Mergentheim, Germany

Location

Gesundheitszentrum Mathias Hospital

Rheine, 48431, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, Germany

Location

Diabetes/ Endokrin sektion

Lund, Sweden

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Michael Ruge

  Vivostat

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

DE (3); DK (1); SE (1)