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

NCT02641548 | Terminated

• 1 other identifier: OLL-524811
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Complications

Keywords

Diabetic foot; Diabetic foot disease; Skin fissures; Xerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Severity of skin dryness

  Once every 4 weeks for approx. 6 months

• Number of participants for whom the fissures develop into ulcers

  Once every 4 weeks for approx. 6 months

• Number of participants with complications

  Once every 4 weeks for approx. 6 months

Study Arms (2)

Silicone sock+heel cream

EXPERIMENTAL

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

Heel cream

ACTIVE COMPARATOR

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

Other: Heel cream

Interventions

Sock of silicone DEVICE

Silicone sock+heel cream

Heel cream OTHER

Also known as: Footmender

Heel cream; Silicone sock+heel cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes diagnosis, and
• Deep heel fissures

You may not qualify if:

• Factors associated with increased risk of complications:
• known allergy or hypersensitivity to silicone or ingredients in cream
• other skin conditions that make use of sock or cream inappropriate
• strongly fluctuating foot edema
• ulcer in part of the foot that the sock is in contact with
• 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.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University Hospital

Örebro, Örebro County, Sweden

Location

Related Publications (4)

• 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.

  PMID: 12046488 BACKGROUND

• 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.

  PMID: 22271742 BACKGROUND

• 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.

  PMID: 23815476 BACKGROUND

• 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.

  PMID: 22341798 BACKGROUND

MeSH Terms

Conditions

Diabetes Complications; Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies

Study Officials

• Gustav Jarl, PhD

  Region Örebro County, Örebro, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Certified Prosthetist and Orthotist

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: February 18, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)