| - candidate number | 2811 |
| - NTR Number | NTR1091 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 15-okt-2007 |
| - Secondary IDs | wordt doorgegeven |
| - 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. |
| - 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. |
| - ACRONYM | DIAFOS trial |
| - 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. |
| - Healt Condition(s) or Problem(s) studied | Diabetes Mellitus |
| - 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. |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Not applicable |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jan-2008 |
| - planned closingdate | 31-dec-2011 |
| - Target number of participants | 240 |
| - 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) |
| - Primary outcome | Proportion of patients with a plantar diabetic foot ulcer within an 18-month follow-up period. |
| - 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). |
| - Timepoints | Baseline assessment; Entry visit (0 months); Follow-up visits each 3 months for 18 months |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | PhD S.A. Bus |
| - CONTACT for SCIENTIFIC QUERIES | PhD S.A. Bus |
| - Sponsor/Initiator | Academic Medical Center (AMC), Amsterdam |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Amsterdam, ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - 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. |
| - Main changes (audit trail) | |
| - RECORD | 15-okt-2007 - 20-mrt-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl