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Plasma Rich Growth Factors in Venous Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Basque Health Service.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Javier Urraca García de Madinabeitia, Basque Health Service
ClinicalTrials.gov Identifier:
NCT01491438
First received: December 7, 2011
Last updated: February 6, 2013
Last verified: December 2011
  Purpose

OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment.

SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment.

Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit.

STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.


Condition Intervention
Venous Ulcers
Procedure: PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary
Procedure: Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial to Determinate the Effectiveness and Safety of Plasma Rich Growth Factors (PRGF) in Venous Ulcers Treatment

Resource links provided by NLM:


Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • Ulcers closed [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
    Patients will be followed during 12 weeks.


Secondary Outcome Measures:
  • Pruritus (Yes/No) [ Time Frame: During 12 weeks of treatment (in each visit) ] [ Designated as safety issue: Yes ]
  • Pain (through VAS scale) [ Time Frame: During 12 weeks of treatment (in each visit) ] [ Designated as safety issue: Yes ]
  • Signs of infection (Yes/No) [ Time Frame: During 12 weeks of treatment (in each visit) ] [ Designated as safety issue: Yes ]
  • Wound surface (in cm2) measured through PUSH scale [ Time Frame: Every 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 214
Study Start Date: November 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRGF and conventional treatment
PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)
Procedure: PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary

PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)during 12 weeks.

Types of dressing: enzyme cutting dressing (collagenase), hydrogel, polymeric foam, alginate dressing, hydrocolloid hydrofiber dressing, silver dressing, coal and silver dressing, argentum sulfadiazine dressing, polyurethane or caster hydrocolloid dressing

Active Comparator: Conventional treatment alone
Conventional treatment (cleaning, debridement of the wound and application of the corresponding dressing and using of antibiotics if necessary) twice a week (days 1 and 4).
Procedure: Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary
Twice a week (days 1 and 4) during 12 weeks

Detailed Description:

An open, randomized, of parallel groups, and controlled clinical trial. Patients will be allocated on first come to one of the two treatment groups using a block random sequence generated by computer that will remain hidden from the researchers and patients until allocation.

Experimental group: PRGF together with the corresponding dressing according to annex IV.

Control group: Corresponding dressing according to annex IV.

Both groups will be submitted to a cleaning, debridement, occlusive dressing and use of antibiotic if necessary in each visit.

After signing consent form, and previously of randomization, patients will be submitted to a blood extraction where it will be determinate: Albumine (in g/dl), Hemoglobin (in g/dl), Hematocrit (in %), Creatinine (in mg/dl). If patients have data collected through previous analysis performed until 30 days before, it will not be necessary a new extraction.

Patients will be also submitted to an initial valuation of:

  • medical antecedents: history of chronic venous insufficiency, previous medical treatments.
  • general state: dependence grade through Barthel index, mobility, ankle arm index.
  • ulcer characteristics:exudate, sing of location of ulcer, antiquity of ulcer, tunneling,infection, pain through a Visual Analogue Scale (VAS).
  • Anthropometric characteristics; Weight, height and Body Mass Index (BMI).

Patients will go to the physician's consult every fours days (on Monday or Tuesday and Thursday or Friday). When one ulcer is closed, patient will go to physician's consult to confirm that it remains closed at seven and fifteen days.

In both intervention and control groups, the bad evolution of ulcer with deterioration at least during four consecutive weeks, will obligate to ask a preferred inter-consultation with Vascular Surgery Service.

In each visit the following variables will be measured:

  • Wound surface (in cm2) measured through PUSH scale (Pressure Ulcer Scale for Healing) belonging to GNEAUPP group (National Group to study and advice about pressure ulcers and chronic wounds). This variable will be measured in each visit.
  • Safety variable: Pruritus (Yes/No), Pain (through VAS scale), Sings of infection (Yes/No).

If patient experience one adverse effect which according to judgment of nurse precludes its continuation into the study, the nurse will communicate it to physician who will discharge from study if it is necessary.

All this will be collected in Case Report Form (CRF).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years.
  • Patients with at least one venous ulcer of at least 6 weeks of evolution.
  • Diameter between 0,5-6cm.

Exclusion Criteria:

  • Cutaneous ulcers with an arterial and/or mixed origin.
  • Ankle-arm index <0.9.
  • Concomitant terminal disease with bad prognosis.
  • Hematologic several abnormalities (anemia with hemoglobin <11g/dl, hematocrit <34%, lymphomas and leukemias).
  • Antineoplastic or immunosuppressive treatment.
  • Solid tumors.
  • Nutritional status affectation.
  • Known peripheral neuropathy in patients with diabetes mellitus.
  • At home patient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491438

Contacts
Contact: Javier Urraca 945006669 JAVIER.URRACAGARCIAMADINABEITIA@osakidetza.net

Locations
Spain
Javier Urraca García de Madinabeitia
Vitoria-Gasteiz, Álava, Spain
Sponsors and Collaborators
Basque Health Service
Investigators
Principal Investigator: Javier Urraca Basque Public Health Service-Osakidetza
  More Information

No publications provided

Responsible Party: Javier Urraca García de Madinabeitia, Primary care Physician, Basque Health Service
ClinicalTrials.gov Identifier: NCT01491438     History of Changes
Other Study ID Numbers: ULC01
Study First Received: December 7, 2011
Last Updated: February 6, 2013
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Ulcer
Varicose Ulcer
Cardiovascular Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Mitogens
Anti-Infective Agents
Antitubercular Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014