DiabetesNCT01221194
Therapeutic Stockings to Prevent Foot Ulcers
A study testing Standard therapy and PFC Stockings in people with Diabetes, run by University of Texas Southwestern Medical Center at 4 sites in 2 countries.
Trial summary
1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients. 2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Standard therapy and PFC Stockings
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men or women 18 years old or older
- Diagnosis of Diabetes Mellitus*
- History of diabetes related foot ulceration
- Spanish-speaking subjects will be eligible to participate.
Who cannot join
- Active Charcot Arthropathy
- Gangrene, active infection
- Midfoot or higher level amputation
- Alcohol or substance abuse within 6 months
- Unreliable, unwilling or unable to comprehend informed consent
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Parkland Health & Hospital Systems
Dallas, Texas, 75235
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Scott & White
Temple, Texas, 76502
About this study
- To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.
- To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.
Read the detailed description
We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.
- Conditions
- Diabetes
- Being tested
- Standard therapy, PFC Stockings
- Keywords
- diabetes, foot ulcer prevention, therapeutic stockings
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard therapyBehavioural
Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
PFC StockingsDevice
A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. Receives: Behavioral: Standard therapy |
| PFC Stockings | Active comparator | The stocking therapy group will be given PFC shear reducing stockings to wear. Receives: Device: PFC Stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed Foot Ulcer During Study Time Frame
An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Lavery, University of Texas Southwestern Medical Center
- Investigators
- Lawrence Lavery, DPM, Principal investigator, UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221194
- Sponsor's protocol ID
- STU 082010-090
- Status last verified
- Aug 2020
- First submitted
- 13 Oct 2010
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Stockings to Prevent Foot Ulcers
- ClinicalTrials.gov ID
- NCT01221194
- Acronym / sponsor ID
- STU 082010-090
- Conditions
- Diabetes
- Keywords
- diabetes, foot ulcer prevention, therapeutic stockings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.
- To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.
Detailed description
We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | Active comparator | Behavioral: Standard therapyStandard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. |
| PFC Stockings | Active comparator | Device: PFC StockingsThe stocking therapy group will be given PFC shear reducing stockings to wear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women 18 years old or older
- Diagnosis of Diabetes Mellitus*
- History of diabetes related foot ulceration
- Spanish-speaking subjects will be eligible to participate.
Key exclusion criteria (5 listed)
- Active Charcot Arthropathy
- Gangrene, active infection
- Midfoot or higher level amputation
- Alcohol or substance abuse within 6 months
- Unreliable, unwilling or unable to comprehend informed consent
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 |
|---|---|---|
| Standard therapyStandard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear. | Behavioural | Standard therapy |
| PFC StockingsA pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases. | Device | PFC Stockings |
Primary outcome
Number of Participants Who Developed Foot Ulcer During Study Time Frame
Time frame: 30 months
An ulceration will be defined as full thickness loss of epidermis and dermis or involvement of deeper structures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lawrence Lavery, DPM principal investigator
UT Southwestern Medical Center at Dallas
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard therapy and PFC Stockings in people with Diabetes, run by University of Texas Southwestern Medical Center at 4 sites in 2 countries.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Developed Foot Ulcer During Study Time Frame (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2020.