Diabetes ComplicationsNCT02641548
Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes
A study testing Sock of silicone and Heel cream in people with Diabetes Complications, run by Region Örebro County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- Sock of silicone and Heel cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 18 Feb 2016to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes diagnosis, and
- Deep heel fissures
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes -a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diabetes Complications
- Being tested
- Sock of silicone, Heel cream
- Keywords
- Diabetic foot, Diabetic foot disease, Skin fissures, Xerosis
- Medical subject headings
- Diabetes Complications, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sock of siliconeDevice
Heel creamOther
Also called Footmender
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sock of silicone; Other: Heel cream |
| Heel cream | Active comparator | Every evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet Receives: Other: Heel cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Once every 4 weeks for approx. 6 months
Secondary outcomes (3)
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.
Measured: Once every 4 weeks for approx. 6 months
Number of participants for whom the fissures develop into ulcers
The presence of ulcers is judged by the podiatrist at the visits.
Measured: 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.
Measured: Once every 4 weeks for approx. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start18 Feb 2016
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: Due to difficulties in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Jarl, Region Örebro County
- Investigators
- Gustav Jarl, PhD, Principal investigator, Region Örebro County, Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641548
- Sponsor's protocol ID
- OLL-524811
- Status last verified
- May 2025
- First submitted
- 23 Dec 2015
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only group level data will be published
Publications
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.
PubMed 12046488Bakker 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.
PubMed 22271742Kang 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.
PubMed 23815476Oe 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.
PubMed 22341798
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicone Sock as Treatment of Deep Heel Fissures in People With Diabetes -a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02641548
- Acronym / sponsor ID
- OLL-524811
- Conditions
- Diabetes Complications
- Keywords
- Diabetic foot, Diabetic foot disease, Skin fissures, Xerosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulties in recruiting participants
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone sock+heel cream | Experimental | Device: Sock of silicone, Other: Heel creamEvery 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 | Other: Heel creamEvery evening a cream (Footmender, Auxilum Cura Innovatio, Dublin, Ireland, European Patent 2522342) is applied to the feet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes diagnosis, and
- Deep heel fissures
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sock of silicone | Device | Silicone sock+heel cream |
| Heel creamAlso: Footmender | Other | Heel cream, Silicone sock+heel cream |
Primary outcome
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.
3 secondary outcomes
Severity of skin dryness
Time frame: Once every 4 weeks for approx. 6 months
Number of participants for whom the fissures develop into ulcers
Time frame: Once every 4 weeks for approx. 6 months
Number of participants with complications
Time frame: Once every 4 weeks for approx. 6 months
Results and safety
The study was stopped early (reason given: Due to difficulties in recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Background: PubMed 12046488Pham 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.
- Background: PubMed 22271742Bakker 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.
- Background: PubMed 23815476Kang 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.
- Background: PubMed 22341798Oe 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.
- Individual participant dataSharing planned: No. Only group level data will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Jarl, PhD principal investigator
Region Örebro County, Örebro, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sock of silicone and Heel cream in people with Diabetes Complications, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to difficulties in recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of healing of deep heel fissures (time frame: Once every 4 weeks for approx. 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641548, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.