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

Region Örebro County25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Complications

Interventions

Sock of siliconeDEVICE

Heel creamOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Örebro University Hospital

Örebro, Örebro County, Sweden

Outcomes

Primary Outcomes

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.