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

Not Applicable

• Conditions: Diabetes Complications
• Interventions: Device: Sock of silicone; Other: Heel cream

• Registration Number: NCT02641548
• Lead Sponsor: Region Örebro County

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-15
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone sock+heel cream	Heel cream	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.
Silicone sock+heel cream	Sock of silicone	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.
Heel cream	Heel cream	Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Örebro University Hospital; 🇸🇪 Örebro, Sweden