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Due to difficulties in recruiting participants
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Heel cream | Active Comparator | Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sock of silicone | Device |
| ||
| Heel cream |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants for whom the fissures develop into ulcers |
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Inclusion Criteria:
Exclusion Criteria:
Factors associated with increased risk of complications:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Jarl, PhD | Region Örebro County, Örebro, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University Hospital | Örebro | Örebro County | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12046488 | Background | 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. | |
| 22271742 | 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. |
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Only group level data will be published
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| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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|
The presence of ulcers is judged by the podiatrist at the visits. |
| Once every 4 weeks for approx. 6 months |
| 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 |
| 23815476 | 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. |
| 22341798 | 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. |
| D002318 |
| Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003929 | Diabetic Neuropathies |