Neuropathic Foot Ulceration in Individuals With DiabetesNCT00304733
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
A study testing cast vs. shoe in people with Neuropathic Foot Ulceration in Individuals With Diabetes, run by Rehabilitation Centre Amsterdam at 1 site in Netherlands.
Trial summary
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Foot Ulceration in Individuals With Diabetes
- What is being tested?
- cast vs. shoe
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2001to Apr 2005
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diabetes
- neuropathic ulcer grade 1/2 (wagner scale)
- confirmed sensory neuropathy
Who cannot join
- osteomyelitis patients unable to walk
- life threatening co-morbidity ankle/brachial index , 0.4
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 hm
About this study
Objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
Read the detailed description
In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.
- Being tested
- cast vs. shoe
- Keywords
- neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cast vs. shoeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
wound surface area reduction
Secondary outcomes (1)
time to wound healing (days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startAug 2001
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Foot Ulceration in Individuals With DiabetesStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 43 participants
Sponsor and investigators
- Lead sponsor
- Rehabilitation Centre Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc., Ontwikkelingsfonds Orthopedisch maatschoeisel
- Investigators
- f. b. van de weg, m.d., Study chair, rehabiliation centre amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304733
- Sponsor's protocol ID
- 2024
- Status last verified
- Aug 2001
- First submitted
- 16 Mar 2006
- Last updated
- 20 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic Foot Ulceration
- ClinicalTrials.gov ID
- NCT00304733
- Acronym / sponsor ID
- 2024
- Keywords
- neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants
- Lead sponsor
- Rehabilitation Centre AmsterdamUniversity, hospital or other
- Collaborators
- ConvaTec Inc., Ontwikkelingsfonds Orthopedisch maatschoeisel
- Study start
- Aug 2001
- Study completion
- Apr 2005
- First posted
- 20 Mar 2006 (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 compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
Detailed description
In this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed diabetes
- neuropathic ulcer grade 1/2 (wagner scale)
- confirmed sensory neuropathy
Key exclusion criteria (2 listed)
- osteomyelitis patients unable to walk
- life threatening co-morbidity ankle/brachial index , 0.4
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 |
|---|---|---|
| cast vs. shoe | Device | – |
Primary outcome
wound surface area reduction
1 secondary outcome
time to wound healing (days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2006.
Related trials for Neuropathic Foot Ulceration in Individuals With Diabetes
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The Instant Effect of Whole Body Vibration in Diabetics
Diabetus Mellitus, Diabetic Foot Ulcer
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.
f. b. van de weg, m.d. study chair
rehabiliation centre amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cast vs. shoe in people with Neuropathic Foot Ulceration in Individuals With Diabetes, run by Rehabilitation Centre Amsterdam at 1 site in Netherlands.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 2006. 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 Netherlands. 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?
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?
wound surface area reduction. 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 20 Mar 2006.