Plasma Rich Growth Factors in Venous Ulcers

NCT01491438 | Unknown

• 1 other identifier: ULC01
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Ulcers

Outcome Measures

Primary Outcomes (1)

• Ulcers closed

  Patients will be followed during 12 weeks.

  at 12 weeks of treatment

Secondary Outcomes (4)

• Pruritus (Yes/No)

  During 12 weeks of treatment (in each visit)

• Pain (through VAS scale)

  During 12 weeks of treatment (in each visit)

• Signs of infection (Yes/No)

  During 12 weeks of treatment (in each visit)

• Wound surface (in cm2) measured through PUSH scale

  Every 4 days

Study Arms (2)

PRGF and conventional treatment

EXPERIMENTAL

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

Conventional treatment alone

ACTIVE COMPARATOR

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

Interventions

PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary PROCEDURE

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

PRGF and conventional treatment

Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary PROCEDURE

Twice a week (days 1 and 4) during 12 weeks

Conventional treatment alone

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Javier Urraca García de Madinabeitia

Vitoria-Gasteiz, Álava, Spain

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Javier Urraca

  Basque Public Health Service-Osakidetza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Urraca

CONTACT

945006669; JAVIER.URRACAGARCIAMADINABEITIA@osakidetza.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary care Physician

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 14, 2011
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2011-12

Locations

ES (1)