Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes

Phase 3

Completed

• Conditions: Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot; Nutritional, Metabolic, Endocrine; Type 1 and Type 2 diabetes mellitus

• Registration Number: ISRCTN62524796
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25428268 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28644115

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-28
• Study Completion: 2015-06-30
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 529

Inclusion Criteria

1. Type 1 or type 2 diabetes mellitus
2. Age 18 years or over
3. An ulcer of the heel (below the malleoli and affecting the skin overlying the calcaneum) of national pressure ulcer advisory panel-european pressure ulcer advisory panel (NPUAPEPUAP) Grade 24, which has been present for two or more weeks. If there is more than one heel ulcer, one will be selected as the index ulcer and this will be generally the largest or the most clinically significant.
4. Subjects who are both able and willing to give written informed consent
Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Frailty or disability which would mean that participation in the study might have an adverse effect of patient well being and mood
2. The need for any offloading device to be nonremovable
3. The likelihood of protocol violation because of planned travel
4. Pregnancy or the possibility of pregnancy
5. Those who withhold consent
6. Active participation in another study of a wound care product
7. The use of topical negative pressure or application of larvae to the index heel ulcer

Study & Design

• Study Type: Interventional
• Study Design: Not specified