Diabetic FootPhase 3NCT01005264
Removable Walker for Neuropathic Ulcers
A Phase 3 study testing non-removable fiberglass and Stabil-D® in people with Diabetic Foot, run by IRCCS Multimedica at 1 site in Italy.
Trial summary
1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer 2. Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- non-removable fiberglass and Stabil-D®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Mar 2009
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND
- The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts.
Who cannot join
- Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot,
- Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage,
- The probe-to-bone maneuver was required to be negative,
- Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis,
- Use of steroids or cytostatic drugs,
- Presence of sensory, motor, or visual problems that could impair functional autonomy,
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- Active ulcer on the contralateral foot,
- Previous major amputation of the contralateral limb,
- Previous or current deep venous leg thrombosis, OR
- Mental disorders interfering with patient compliance.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Diabetic Foot Center - IRCCS Multimedica
Sesto San Giovanni, Milan, 20099
About this study
Official title: Effectiveness of Removable Walker Cast Versus Non-removable Fiberglass Off-bearing Cast in the Healing of Diabetic Plantar Foot Ulcer- a Randomized Controlled Trial
- Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer
- Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
Read the detailed description
Study design:
Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).
- Conditions
- Diabetic Foot
- Being tested
- non-removable fiberglass, Stabil-D®
- Keywords
- diabetic foot, neuropathic plantar ulcer, ulcer healing, non-removable total contact cast, removable cast walker
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-removable fiberglassDevice
Also called Softcast3M®, 3M Health Care, St. Paul, MN (USA)
Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus
Stabil-D®Device
Also called Podartis srl, Montebelluna, Treviso, Italy
Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole
| Study group | Role | What they receive |
|---|---|---|
| non-removable fiberglass | Active comparator | Softcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus Receives: Device: non-removable fiberglass |
| Stabil-D® | Active comparator | Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole Receives: Device: Stabil-D® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in ulcer size
Measured: at 90th day
Secondary outcomes (1)
Complete healing rate at the end of the study
Measured: at 90th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Diabetic FootStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Multimedica
- Sponsor type
- University, hospital or other
- Investigators
- Ezio Faglia, MD, Principal investigator, Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005264
- Sponsor's protocol ID
- 05/2007cardiovascolare
- Status last verified
- Oct 2009
- First submitted
- 19 Oct 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Caravaggi C, Sganzaroli A, Fabbi M, Cavaiani P, Pogliaghi I, Ferraresi R, Capello F, Morabito A. Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected plantar ulcers: a randomized prospective trial. Diabetes Care. 2007 Oct;30(10):2577-8. doi: 10.2337/dc07-0990. Epub 2007 Jun 11. No abstract available.
PubMed 17563333Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes Care. 2007 Mar;30(3):586-90. doi: 10.2337/dc06-1750.
PubMed 17327325Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes Care. 2000 Dec;23(12):1746-51. doi: 10.2337/diacare.23.12.1746.
PubMed 11128345Faglia E, Caravaggi C, Clerici G, Sganzaroli A, Curci V, Vailati W, Simonetti D, Sommalvico F. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes Care. 2010 Jul;33(7):1419-23. doi: 10.2337/dc09-1708. Epub 2010 Mar 31.
PubMed 20357377
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Removable Walker Cast Versus Non-removable Fiberglass Off-bearing Cast in the Healing of Diabetic Plantar Foot Ulcer- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01005264
- Acronym / sponsor ID
- 05/2007cardiovascolare
- Conditions
- Diabetic Foot
- Keywords
- diabetic foot, neuropathic plantar ulcer, ulcer healing, non-removable total contact cast, removable cast walker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- IRCCS MultimedicaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Oct 2009 (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.
- Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer
- Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
Detailed description
Study design:
Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-removable fiberglass | Active comparator | Device: non-removable fiberglassSoftcast3M®, 3M Health Care, St. Paul, MN (USA) were used for construction of the pressure-relief apparatus |
| Stabil-D® | Active comparator | Device: Stabil-D®Composed of a specifically designed rigid, boat shaped, and fully rocker bottom sole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND
- The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus > 25 volts.
Key exclusion criteria (10 listed)
- Presence of an ankle-brachial pressure index (ABI) < 0.9 and/or transcutaneous oxygen tension (TcPO2) < 50 mmHg tested on the dorsum of the foot,
- Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage,
- The probe-to-bone maneuver was required to be negative,
- Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis,
- Use of steroids or cytostatic drugs,
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 |
|---|---|---|
| non-removable fiberglassAlso: Softcast3M®, 3M Health Care, St. Paul, MN (USA)Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus | Device | non-removable fiberglass |
| Stabil-D®Also: Podartis srl, Montebelluna, Treviso, ItalyStabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole | Device | Stabil-D® |
Primary outcome
Decrease in ulcer size
Time frame: at 90th day
1 secondary outcome
Complete healing rate at the end of the study
Time frame: at 90th day
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 30 Oct 2009.
- Results publication: PubMed 17563333Caravaggi C, Sganzaroli A, Fabbi M, Cavaiani P, Pogliaghi I, Ferraresi R, Capello F, Morabito A. Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected plantar ulcers: a randomized prospective trial. Diabetes Care. 2007 Oct;30(10):2577-8. doi: 10.2337/dc07-0990. Epub 2007 Jun 11. No abstract available.
- Results publication: PubMed 17327325Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes Care. 2007 Mar;30(3):586-90. doi: 10.2337/dc06-1750.
- Results publication: PubMed 11128345Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes Care. 2000 Dec;23(12):1746-51. doi: 10.2337/diacare.23.12.1746.
- Derived from this study: PubMed 20357377Faglia E, Caravaggi C, Clerici G, Sganzaroli A, Curci V, Vailati W, Simonetti D, Sommalvico F. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes Care. 2010 Jul;33(7):1419-23. doi: 10.2337/dc09-1708. Epub 2010 Mar 31.
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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.
Ezio Faglia, MD principal investigator
Diabetic Foot Center - IRCCS Multimedica, Sesto San Giovanni (Milan), Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing non-removable fiberglass and Stabil-D® in people with Diabetic Foot, run by IRCCS Multimedica at 1 site in Italy.
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 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 30 Oct 2009. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Decrease in ulcer size (time frame: at 90th day). 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 NCT01005264, 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 30 Oct 2009.