Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes
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|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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications||Device: Sock of silicone Other: Heel cream||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Gustav Jarl, PhDfirstname.lastname@example.org|
|Örebro University Hospital||Recruiting|
|Contact: Gustav Jarl email@example.com|
|Principal Investigator:||Gustav Jarl, PhD||Region Örebro County, Örebro, Sweden|