Venous leg ulcer Circulatory System Varicose veins of lower extremities
Conditions
Interventions
The participating primary healthcare centres will be randomly allocated to the following three groups:
Group A: Compression therapy + low-adherence, simple dressings + acupuncture
Sponsors
Carlos III Health Institute (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, no age limit 2. Patients with venous leg ulcers who request treatment by a medical professional (doctor or nurse) at one of the Primary Healthcare Clinics in the Sevilla-Sur Health District taking part in the study, with at least one active venous leg ulcer (open, clinical, etiological, anatomical, pathological classification [CEAP] C6) with a diameter exceeding 1 cm
Exclusion criteria
Exclusion criteria: 1. Arterial pathology (systolic pressure in the ankle of less than 80 mmHg or ankle/arm systolic index less than 0.8) 2. Diabetic ulcer of the foot, rheumatoid arthritis or systemic vasculitis 3. Use of anticoagulants 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete healing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete healing at 3 months after beginning treatment 2. Changes in the size of the surface area of the ulcer, assessed at 3, 6 and 12 months 3. Pain intensity measured on a visual analogue scale, assessed at 3, 6 and 12 months 4. Health-related quality of life, assessed using the 12-item Short Form health survey (version 2) at 3, 6 and 12 months | — |
Countries
Spain
Outcome results
None listed