Clinical trial NCT02641548: Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes
Official title: Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes -a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Complications
Keywords: Diabetic foot
Diabetic foot disease
Skin fissures
Xerosis
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of healing of deep heel fissures
timeFrame: Once every 4 weeks for approx. 6 months
measure: Time to healing of deep heel fissures
timeFrame: Once every 4 weeks for approx. 6 months
Secondary outcomes:
measure: Severity of skin dryness
timeFrame: Once every 4 weeks for approx. 6 months
measure: Number of participants for whom the fissures develop into ulcers
timeFrame: Once every 4 weeks for approx. 6 months
measure: Number of participants with complications
timeFrame: Once every 4 weeks for approx. 6 months
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Region Örebro County, Örebro, Sweden
name: Gustav Jarl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pham HT, Exelbert L, Segal-Owens AC, Veves A. A prospective, randomized, controlled double-blind study of a moisturizer for xerosis of the feet in patients with diabetes. Ostomy Wound Manage. 2002 May;48(5):30-6.
citation: Bakker K, Apelqvist J, Schaper NC; International Working Group on Diabetic Foot Editorial Board. Practical guidelines on the management and prevention of the diabetic foot 2011. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:225-31. doi: 10.1002/dmrr.2253. No abstract available.
citation: Kang BC, Kim YE, Kim YJ, Chang MJ, Choi HD, Li K, Shin WG. Optimizing EEMCO guidance for the assessment of dry skin (xerosis) for pharmacies. Skin Res Technol. 2014 Feb;20(1):87-91. doi: 10.1111/srt.12089. Epub 2013 Jul 2.
citation: Oe M, Sanada H, Nagase T, Minematsu T, Ohashi Y, Kadono T, Ueki K, Kadowaki T. Factors associated with deep foot fissures in diabetic patients: a cross-sectional observational study. Int J Nurs Stud. 2012 Jun;49(6):739-46. doi: 10.1016/j.ijnurstu.2012.01.007. Epub 2012 Feb 14.