Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes -a Randomized Controlled Trial

Conditions
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Diabetes Complications

Intervention / Treatment
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* Device: Sock of silicone
* Other: Heel cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes diagnosis, and Deep heel fissures Exclusion Criteria: Factors associated with increased risk of complications: known allergy or hypersensitivity to silicone or ingredients in cream other skin conditions that make use of sock or cream inappropriate strongly fluctuating foot edema ulcer in part of the foot that the sock is in contact with 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silicone sock+heel cream<br>Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet and a sock of silicone is used every night. | Device: Sock of silicone<br> <br> Other: Heel cream<br> <br> * Other names: Footmender;|
| Active Comparator: Heel cream<br>Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet | Other: Heel cream<br> <br> * Other names: Footmender;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of healing of deep heel fissures | 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. | Once every 4 weeks for approx. 6 months | 
| Time to healing of deep heel fissures | A survival analysis is conducted on the same variable as above. | Once every 4 weeks for approx. 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of skin dryness | 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. | Once every 4 weeks for approx. 6 months | 
| Number of participants for whom the fissures develop into ulcers | The presence of ulcers is judged by the podiatrist at the visits. | Once every 4 weeks for approx. 6 months | 
| Number of participants with complications | 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. | Once every 4 weeks for approx. 6 months |