Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02641548
Recruitment Status : Unknown
Verified October 2018 by Gustav Jarl, Region Örebro County.
Recruitment status was:  Recruiting
First Posted : December 29, 2015
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gustav Jarl, Region Örebro County

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.

Condition or disease Intervention/treatment Phase
Diabetes Complications Device: Sock of silicone Other: Heel cream Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes -a Randomized Controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Footmender




Primary Outcome Measures :
  1. Proportion of healing of deep heel fissures [ Time Frame: Once every 4 weeks for approx. 6 months ]
    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.

  2. Time to healing of deep heel fissures [ Time Frame: Once every 4 weeks for approx. 6 months ]
    A survival analysis is conducted on the same variable as above.


Secondary Outcome Measures :
  1. Severity of skin dryness [ Time Frame: Once every 4 weeks for approx. 6 months ]
    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.

  2. Number of participants for whom the fissures develop into ulcers [ Time Frame: Once every 4 weeks for approx. 6 months ]
    The presence of ulcers is judged by the podiatrist at the visits.

  3. Number of participants with complications [ Time Frame: Once every 4 weeks for approx. 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641548


Contacts
Layout table for location contacts
Contact: Gustav Jarl, PhD +46-70-7454678 gustav.jarl@regionorebrolan.se

Locations
Layout table for location information
Sweden
Örebro University Hospital Recruiting
Örebro, Sweden
Contact: Gustav Jarl       gustav.jarl@regionorebrolan.se   
Sponsors and Collaborators
Region Örebro County
Investigators
Layout table for investigator information
Principal Investigator: Gustav Jarl, PhD Region Örebro County, Örebro, Sweden
Publications:
Layout table for additonal information
Responsible Party: Gustav Jarl, PhD, Certified Prosthetist and Orthotist, Region Örebro County
ClinicalTrials.gov Identifier: NCT02641548    
Other Study ID Numbers: OLL-524811
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only group level data will be published
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases