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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-18

Study Completion Date

2019-04-01

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.

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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.

Conditions

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Diabetes Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Silicone sock+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.

Group Type EXPERIMENTAL

Sock of silicone

Intervention Type DEVICE

Heel cream

Intervention Type OTHER

Heel cream

Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet

Group Type ACTIVE_COMPARATOR

Heel cream

Intervention Type OTHER

Interventions

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Sock of silicone

Intervention Type DEVICE

Heel cream

Intervention Type OTHER

Other Intervention Names

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Footmender

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No