A feasibility study to evaluate the effect of Vivostat® Platelet Rich Fibrin (PRF®) in the treatment of diabetic foot ulcers - PRF Diabetic Foot Study

• Conditions: - Diabetic foot ulcers Texas Grade I placed at or below the anchle-Non-ischaemic, non-infected ulcers

• Registration Number: EUCTR2009-011755-47-DE
• Lead Sponsor: Vivostat A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Age: >18 years
2.Type I or Type II Diabetes Mellitus
3.Ulcer(s) at or below the ankle which have been present for at least 4 weeks, and have received best practice care
4.Ulcer area between 0,5 and 16 cm2 after sharp debridement
5.If there is more than one ulcer the investigator shall choose one index ulcer to be treated (typically the largest one). The other ulcers will receive standard care and are not to be included in the study. A maximum of 2 ulcers is allowed at the foot investi-gated
6.Ulcer type: University of Texas grade IA.
7.Evidence of adequate arterial perfusion: Toe pressure reading of = 30 mmHg or if toe is missing, transcutaneous oxygen (TcPO2) of = 30mmHg on the foot.
8.Patient foot is appropriately off loaded (contact cast, pneumatic walking cast)
9.Orthopaedic assessment has been completed to rule out a mechanical source of ulcera-tion
10.Relative wound area reduction less than 50% from week –3 to week 0 (pre-screening period)
11.Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Clear indication for surgery (vascular reconstruction or skin transplant)
2.Ulcer with exposed bone or tendon
3.Bone involvement (probe to bone or x-ray)
4.Patients with 3 ulcers or more on at the foot investigated
5.Osteomyelitis
6.Clinical signs of infections in the ulcer studied
7.Patients with Necrosis in the ulcer that cannot be removed by debridement at Week 0
8.Patients with known Methicillin-resistant Staphylococcus aureus (MRSA) in the specific ulcer treated in the study
9.Malnutrition. Albumin < 2,5g/dl
10.Ulcers resulting from electrical, chemical, radiation burns
11.HbA1c > 12%
12.Male : Hb < 8 g/dl Female : Hb < 7 g/dl
13.Platelet count <140 *109/l
14.Pregnancy and fertile women not practising sufficient birth control
15. Fertile women with a positive pregnancy test week 0
16.Lactating women
17.Patients on haemodialysis
18.Limb ischemia requiring re-vascularisation or impending amputation
19.History of peripheral vascular repair within 4 weeks prior to randomization
20.Bleeding disorders, haemophilia, sickle cell disease, thrombocytopenia, and leukaemia or blood dyscrasias
21.Current treatment for malignancy or neoplastic disease or collagen scular disease
22.Patient has a highly communicable disease or diseases that may limit follow
23.Patients with immuno-compromised conditions, hepatitis, active tuberculosis
24.Patient has inadequate venous access to draw blood
25.History of alcohol or drug abuse within the last year prior to randomization
26.Patient known to have psychological, developmental, physical, emotional or social dis-order or other ailments that may interfere with the study requirements
27.Patients enrolled in an other clinical trial for wound treatment within 30 days prior to enrolment
28.Non-compliance in the screening period
29.Patients who have received growth factor therapy e.g. becaplermin within 7 days prior to enrolment
30.Relative wound area reduction greater than 50% from Week-3 to Week 0 (Run-in)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified