- candidate number | 2811 |
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- NTR Number | NTR1091 |
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- ISRCTN | ISRCTN wordt niet meer aangevraagd |
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- Date ISRCTN created | |
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- date ISRCTN requested | |
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- Date Registered NTR | 15-okt-2007 |
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- Secondary IDs | wordt doorgegeven |
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- Public Title | The effectiveness of using plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration rate in diabetic patients: A Randomized Controlled Trial. |
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- Scientific Title | The effectiveness of using plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration rate in diabetic patients: A Randomized Controlled Trial.
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- ACRONYM | DIAFOS trial |
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- hypothesis | Therapeutic footwear of which adequate off-loading properties are guaranteed and monitored by dynamic plantar pressure assessment will result in a reduced plantar re-ulceration rate in diabetic patients with prior plantar foot ulceration compared to footwear manufactured and monitored according to current practice. |
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- Healt Condition(s) or Problem(s) studied | Diabetes Mellitus |
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- Inclusion criteria | 1. Age >18 and <85 years old;
2. Diabetes mellitus type 1 or 2;
3. Loss of protective sensation due to peripheral neuropathy;
4. History of plantar foot ulceration within the last 18 months;
5. A new therapeutic footwear prescription.
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- Exclusion criteria | 1. Active foot ulceration;
2. Amputation proximal to the metatarsal bones;
3. Severe illness that would make 18-months survival unlikely;
4. The use of walking aids that contribute to offloading the foot;
5. Parallel participation in another study that may influence the outcomes of this study;
6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study.
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- mec approval received | yes |
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- multicenter trial | yes |
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- randomised | yes |
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- masking/blinding | Double |
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- control | Not applicable |
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- group | Parallel |
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- Type | 2 or more arms, randomized |
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- Studytype | intervention |
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- planned startdate | 1-jan-2008 |
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- planned closingdate | 31-dec-2011 |
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- Target number of participants | 240 |
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- Interventions | Therapeutic (orthopedic) footwear optimized and monitored using plantar pressure distribution measurement (Intervention group).
Therapeutic (orthopedic) footwear manufactured and monitored according to current clinical practice (Control group)
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- Primary outcome | Proportion of patients with a plantar diabetic foot ulcer within an 18-month follow-up period. |
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- Secondary outcome | 1. In-shoe peak plantar pressures;
2. Barefoot peak plantar pressures;
3. Cost-effectiveness and cost-utility;
4. Perceived footwear usability;
5. Footwear use (adherence);
6. Number of steps made per day (daily activity level). |
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- Timepoints | Baseline assessment;
Entry visit (0 months);
Follow-up visits each 3 months for 18 months |
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- Trial web site | N/A |
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- status | open: patient inclusion |
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- CONTACT FOR PUBLIC QUERIES | PhD S.A. Bus |
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- CONTACT for SCIENTIFIC QUERIES | PhD S.A. Bus |
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- Sponsor/Initiator | Academic Medical Center (AMC), Amsterdam |
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- Funding
(Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Amsterdam, ZON-MW, The Netherlands Organization for Health Research and Development |
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- Publications | N/A |
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- Brief summary | The purpose of this multicenter randomized controlled trial is to assess the effectiveness of incorporating foot pressure measurements in the manufacturing of therapeutic footwear to guarantee adequate off-loading properties and as a method of monitoring the off-loading properties over time in preventing the recurrence of plantar foot ulcers in patients with diabetes mellitus. |
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- Main changes (audit trail) | |
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- RECORD | 15-okt-2007 - 20-mrt-2008 |