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

Diabetes Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02641548
• Other study ID #: OLL-524811
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: May 2021

Study information

• Verified date: October 2018
• Source: Region Örebro County
• Contact: Gustav Jarl, PhD
• Phone: +46-70-7454678
• Email: gustav.jarl[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus

Intervention

Device:
• Sock of silicone

Other:
• Heel cream

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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