RBR‐5d4s4f.

Study name	Effect of therapies combination to healing of venous ulcers, leg pain and self rated health and quality of life of patients in a six‐month follow‐up
Methods	Randomised controlled trial, parallel, open, with 2 study arms
Participants	People with a leg ulcer with clinical signs of impaired venous circulation with or without the low impairment of arterial circulation
Interventions	Intervention followed 3 paths: orientation for all participants on exercising the lower limbs and resting with legs elevated using an educational booklet. Oral supplementary nutrition for all participants using Cubitan 200 mL 3 times a day between meals, for up to 8 weeks, or less in the case of early healing. Application of topical therapy combined with compression therapy, in different ways, for group A (30 participants) and B (30 participants), by random allocation. Topical therapy combined with compression therapy consisted of 3 phases. In the first phase, group A treated with papain 2% combined with Surepress compression therapy, and group B with hydrogel 2% combined with Surepress compression therapy. In the second phase, group A treated with rayon gauze and Unna Boot or Surepress compression therapy and group B with Membracel and Unna Boot or Surepress compression therapy. Third phase covered exercises and elevation with the leg rests and Surepress compression therapy.
Outcomes	Primary outcome: complete wound healing Secondary outcomes: "Progress of cictrization" (Pressure Ulcer Scale for Healing); ulcer healing rate; "resolvability" (calculated by dividing the number of participants who had all wounds completely healed by the total number of study participants); "positive self‐evaluation of health"; quality of life; intensity of pain; "quality of pain" (McGill Pain Questionnaire)
Starting date	1 July 2016
Contact information	Maria Márcia Bachion; E‐mail: mbachion@gmail.com; telephone: +55‐062991464878
Notes	If results from first phase are reported separated for people with venous leg wounds without arterial disease (or if most ulcers are not mixed ulcers, as specified in the protocol) we may be able to pool data.