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Diabetic Foot UlcersPhase 4NCT00770939

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

A Phase 4 study testing Vivostat PRF in people with Diabetic Foot Ulcers, run by Vivostat at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcers
What is being tested?
Vivostat PRF
Type of treatment
Medical device
How many people
60 participants
Where
5 sitesin 3 countries
Study dates
Jul 2008to Aug 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Germany3 sites

  • Diabetes Klinik Bad Mergentheim GmbH

    Bad Mergentheim

  • Gesundheitszentrum Mathias Hospital

    Rheine, 48431

  • Krankenhaus der Barmherzigen Brüder

    Trier

Other trials in Germany

Denmark1 site

  • Woundhealing Centre Bispebjerg Hospital

    Copenhagen, 2400

Other trials in Denmark

Sweden1 site

  • Diabetes/ Endokrin sektion

    Lund

Other trials in Sweden

About this study

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

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.

Being tested
Vivostat PRF
Keywords
Complete healing of chronic diabetic foot ulcers, Platelet Rich Fibrin, Vivostat, Growth factor treatment, Treatment of chronic diabetic foot ulcers
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivostat PRFDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of completely healed ulcers after 12 weeks

    Measured: 12 weeks

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

    Measured: 8 weeks

Secondary outcomes (1)

  1. Granulation rate

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMay 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00770939
Sponsor's protocol ID
2007-001
Status last verified
Oct 2011
First submitted
9 Oct 2008
Last updated
12 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vivostat PRF in people with Diabetic Foot Ulcers, run by Vivostat at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of completely healed ulcers after 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00770939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.

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