Plantar UlcerPhase 2CareFULPreventNCT00803608
The CareFUL Prevention Trial
A Phase 2 study testing TrueContour® Insole in people with Plantar Ulcer and Diabetes, run by DIApedia, LLC at 11 sites in United States.
Trial summary
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Ulcer, Diabetes, Neuropathy Causing Loss of Protective Sensation
- What is being tested?
- TrueContour® Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 2
- 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
- Men and women, 18 years of age or older at the time of consent;
- Clinical diagnosis of Diabetes Mellitus ;
- At least one recently healed plantar MTH-related foot ulcer (>1 week but 4 months since heeling), based on medical records or if these cannot be obtained to the subject's best recollection OR current or recurring hemorrhage into callus under at least one MTH in a patient with a prior MTH related plantar ulcer that has been documented in the medical record;
- Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus >450 kPa;
- Loss of Protective Sensation (refer to Section 7.2.6);
- Community ambulator defined as having the ability or potential for ambulation outside in the community including the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces, or better by subject report;
- Ability to give consent;
- In the opinion of the site PI the subject is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures for the duration of the study.
Who cannot join
- Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;
- Partial foot amputation greater than of two metatarsal heads or rays per foot; toe amputations with the metatarsal heads left in place are permissible; complete foot amputation on one side (i.e. ambulation with a prosthesis) is permissible;
- Charcot process that is active in the opinion of the site PI (requires immobilization beyond use of footwear that would be available through the study);
- A prior ulcer on the plantar aspect of the heel within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- A prior ulcer on the weightbearing aspect of any toe within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
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- A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, if the associated plantar pressure is >450kPa
- Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar pressure;
- Need for an ankle-foot orthoses in the opinion of the site PI or another provider;
- Need for more complex intervention, i.e. the site PI's decision is that the study footwear would not be adequate for the subject's needs, e.g. a rigid outsole or custom molded shoes are deemed necessary.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Blair Medical Associates, Inc
Altoona, Pennsylvania, 16602
Center for Clinical Research, Inc
Castro Valley, California, 94546
Cleveland Clinic Foundation
Cleveland, Ohio, 44193
Diabetic Foot and Wound Center
Denver, Colorado, 80220
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016
Hines VA Hospital
Hines, Illinois, 60141
Innovative Medical Technologies
Los Angeles, California, 90024
Complete Family Footcare
McAllen, Texas, 78501
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Carl T Hayden VA Medical Center
Phoenix, Arizona, 85012
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, 85711
About this study
Official title: Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.
- Being tested
- TrueContour® Insole, Current standard of care insole
- Keywords
- Plantar, Ulcer, Diabetes
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueContour® InsoleDevice
Novel designed insole
Current standard of care insoleDevice
Current Medicare approved A5513 insole
| Study group | Role | What they receive |
|---|---|---|
| 02 | Active comparator | Current standard of care insole Receives: Device: Current standard of care insole |
| 01 | Experimental | TrueContour® insole Receives: Device: TrueContour® Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar UlcerStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- DIApedia, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph L Loomis, MS, Principal investigator, DIApedia, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803608
- Sponsor's protocol ID
- DK05907405A1
- Other IDs
- R44DK059074
- Acronym
- CareFULPrevent
- Status last verified
- Aug 2014
- First submitted
- 4 Dec 2008
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1982-9. doi: 10.2337/dc13-2956. Epub 2014 Apr 23.
PubMed 24760263
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention
- ClinicalTrials.gov ID
- NCT00803608
- Acronym / sponsor ID
- CareFULPrevent / DK05907405A1
- Keywords
- Plantar, Ulcer, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- DIApedia, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Dec 2008 (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.
To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 02 | Active comparator | Device: Current standard of care insoleCurrent standard of care insole |
| 01 | Experimental | Device: TrueContour® InsoleTrueContour® insole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women, 18 years of age or older at the time of consent;
- Clinical diagnosis of Diabetes Mellitus ;
- At least one recently healed plantar MTH-related foot ulcer (>1 week but 4 months since heeling), based on medical records or if these cannot be obtained to the subject's best recollection OR current or recurring hemorrhage into callus under at least one MTH in a patient with a prior MTH related plantar ulcer that has been documented in the medical record;
- Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus >450 kPa;
- Loss of Protective Sensation (refer to Section 7.2.6);
Key exclusion criteria (10 listed)
- Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;
- Partial foot amputation greater than of two metatarsal heads or rays per foot; toe amputations with the metatarsal heads left in place are permissible; complete foot amputation on one side (i.e. ambulation with a prosthesis) is permissible;
- Charcot process that is active in the opinion of the site PI (requires immobilization beyond use of footwear that would be available through the study);
- A prior ulcer on the plantar aspect of the heel within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
- A prior ulcer on the weightbearing aspect of any toe within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
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 |
|---|---|---|
| TrueContour® InsoleNovel designed insole | Device | 01 |
| Current standard of care insoleCurrent Medicare approved A5513 insole | Device | 02 |
Primary outcome
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer
Time frame: every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Derived from this study: PubMed 24760263Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1982-9. doi: 10.2337/dc13-2956. Epub 2014 Apr 23.
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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.
Joseph L Loomis, MS principal investigator
DIApedia, LLC
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TrueContour® Insole in people with Plantar Ulcer and Diabetes, run by DIApedia, LLC at 11 sites in United States.
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 8 inclusion and 10 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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer (time frame: every 3 months). 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 NCT00803608, which also lists 1 linked publication.
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 13 Aug 2014.