Topic: Diabetes Research Network
Conditions
Interventions
Heel cast, fibreglass heel casts in the management of ulcers of the heel in diabetes
control (usual care) versus usual care with the addition of a fibreglass heel cast.
Total study duration is 60 months, follow-up is 12 and 24 weeks (post healing). Single Randomisatio
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of all ulcers healed at 24 weeks (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ulcer-related outcomes - Time to healing, change in ulcer area, adverse events (including infection, major and minor amputation) and ulcer recurrence 2. Patient-related outcomes - Local pain (visual analogue scale), mood and function (EQ-5D), Cardiff Wound Impact Schedule (CWIS) and survival 3. Health economic analysis | — |
Countries
United Kingdom
Outcome results
None listed