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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Complications
• Intervention / Treatment: Device: Sock of silicone; Other: Heel cream

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gustav Jarl, PhD; Phone Number: +46-70-7454678; Email: gustav.jarl@regionorebrolan.se

Study Locations

• Sweden
  • Örebro, Sweden
    • Recruiting
    • Orebro University Hospital
    • Contact: Gustav Jarl; Email: gustav.jarl@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Sock of silicone; Other: Heel cream; Other Names: Footmender
Active Comparator: Heel cream; Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet	Other: Heel cream; Other Names: Footmender

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Gustav Jarl, PhD, Region Örebro County, Örebro, Sweden

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Complications
• Other Study ID Numbers: OLL-524811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only group level data will be published