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

Primary Purpose

Diabetes Complications

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sock of silicone
Heel cream
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Örebro University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silicone sock+heel cream

Heel cream

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
Time to healing of deep heel fissures
A survival analysis is conducted on the same variable as above.

Secondary Outcome Measures

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.
Number of participants for whom the fissures develop into ulcers
The presence of ulcers is judged by the podiatrist at the visits.
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.

Full Information

First Posted
December 23, 2015
Last Updated
October 10, 2018
Sponsor
Region Örebro County
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1. Study Identification

Unique Protocol Identification Number
NCT02641548
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silicone sock+heel cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Heel cream
Arm Type
Active Comparator
Arm Description
Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet
Intervention Type
Device
Intervention Name(s)
Sock of silicone
Intervention Type
Other
Intervention Name(s)
Heel cream
Other Intervention Name(s)
Footmender
Primary Outcome Measure Information:
Title
Proportion of healing of deep heel fissures
Description
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.
Time Frame
Once every 4 weeks for approx. 6 months
Title
Time to healing of deep heel fissures
Description
A survival analysis is conducted on the same variable as above.
Time Frame
Once every 4 weeks for approx. 6 months
Secondary Outcome Measure Information:
Title
Severity of skin dryness
Description
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.
Time Frame
Once every 4 weeks for approx. 6 months
Title
Number of participants for whom the fissures develop into ulcers
Description
The presence of ulcers is judged by the podiatrist at the visits.
Time Frame
Once every 4 weeks for approx. 6 months
Title
Number of participants with complications
Description
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.
Time Frame
Once every 4 weeks for approx. 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes diagnosis, and Deep heel fissures Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustav Jarl, PhD
Phone
+46-70-7454678
Email
gustav.jarl@regionorebrolan.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Jarl, PhD
Organizational Affiliation
Region Örebro County, Örebro, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustav Jarl
Email
gustav.jarl@regionorebrolan.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only group level data will be published
Citations:
PubMed Identifier
12046488
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.
Results Reference
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PubMed Identifier
22271742
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.
Results Reference
background
PubMed Identifier
23815476
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.
Results Reference
background
PubMed Identifier
22341798
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.
Results Reference
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Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes

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