Diabetes Complications
Conditions
Keywords
Diabetic foot, Diabetic foot disease, Skin fissures, Xerosis
Brief summary
This study evaluates the addition of using a sock of silicone to using a heel cream, in the treatment of heel fissures in people with diabetes, aiming at healing the fissures and preventing them from developing into ulcers. Half of the participants will use the silicone sock and a heel cream, the other half will use the cream only.
Detailed description
Dry skin and heel fissures are common complications of diabetes and can develop into hard-to-heal ulcers that eventually can make amputation of the foot necessary. Patients are advised to use heel creams to heal fissures and prevent them from developing into ulcers. Clinical observations have suggested that wearing a silicone sock nighttime can heal fissures, but the additional advantage of using a silicone sock compared to use a heel cream only has not been investigated. Participants will be randomized to an intervention group (silicone sock and heel cream) or a control group (heel cream only) and the healing of fissures and development of new ulcers will be compared between the groups.
Interventions
DEVICESock of silicone
OTHERHeel cream
Sponsors
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diabetes diagnosis, and 2. Deep heel fissures
Exclusion criteria
Factors associated with increased risk of complications: 1. known allergy or hypersensitivity to silicone or ingredients in cream 2. other skin conditions that make use of sock or cream inappropriate 3. strongly fluctuating foot edema 4. ulcer in part of the foot that the sock is in contact with 5. inability of participant or assisting person to handle the silicone sock correctly including daily cleaning. Factors associated with increased risk that complications are not discovered or reported, such as, dementia, language or other communication impairments, intellectual disability or known substance abuse, AND there is no other person who can provide adequate support to the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of healing of deep heel fissures | Once every 4 weeks for approx. 6 months | Heel fissures are defined as fissures involving the dermis. Participants visit a podiatrist who take a photograph later judged by a blinded assessor: presence or absence of deep fissures. |
| Time to healing of deep heel fissures | Once every 4 weeks for approx. 6 months | A survival analysis is conducted on the same variable as above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of skin dryness | Once every 4 weeks for approx. 6 months | The photographs taken by the podiatrist will be judged by a blinded assessor according to the cracks/fissure item from the Specified symptom sum score (SRRC) instrument. |
| Number of participants for whom the fissures develop into ulcers | Once every 4 weeks for approx. 6 months | The presence of ulcers is judged by the podiatrist at the visits. |
| Number of participants with complications | Once every 4 weeks for approx. 6 months | The podiatrist fills in a protocol at each visit, documenting observed complications from the heel cream or silicone sock, such as skin redness, and asks the participants for experienced complications, such as, stings when applying the cream. |
Countries
Sweden
Outcome results
None listed