Feasibility of an Exercise Intervention in Patients with Venous Ulcers

Not Applicable

Completed

• Conditions: Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases; Circulatory System; Venous insufficiency (chronic)(peripheral)

• Registration Number: ISRCTN10205425
• Lead Sponsor: Sheffield Health and Social Care NHS Foundation Trust (UK)

Brief Summary

1. 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26445318 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29077990

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-08
• Study Completion: 2017-05-18
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patient has at least one new venous leg ulcer with a maximum diameter =1 cm
2. Patient has an ankle brachial pressure index (ABPI) =0.8 (taken within last 3 months)
3. Patient is able and willing to tolerate high compression
4. Patient is aged =18 years

Exclusion Criteria

1. Patient is unsuitable or unable to exercise (nurse/doctor judgement)
2. Patients who are not tolerant of high-level lower-limb compression delivered by compression stockings or multilevel bandaging
3. Patients with insulin-controlled diabetes mellitus
4. Pregnant women
5. Patients with coexisting skin conditions, vasculitis, deep venous occlusion or malignant/atypical ulceration
6. Patients who require major surgery
7. Patients with leg ulcers with a maximum diameter of <1 cm
8. Patients who have had an ulcer at the same site within the previous 3 months (updated 30/07/2015: was previously 6 months)
9. Patients are unable or do not wish to consent to participation in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The main outcomes of the study are the ones that are going to define if this feasibility study should proceed to a larger randomised controlled trial. These will be:<br> 1. The definition of an appropriate primary outcome variable<br> 2. Compliance of participation of patients randomized to the exercise group<br> 3. Loss to follow-up<br> 4. Patience preferences in regards to the randomization group<br><br> These will be defined at the trial end (12 months).<br>