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The effectiveness of using plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration rate in diabetic patients: A Randomized Controlled Trial.


- candidate number2811
- NTR NumberNTR1091
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-okt-2007
- Secondary IDswordt doorgegeven 
- Public TitleThe effectiveness of using plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration rate in diabetic patients: A Randomized Controlled Trial.
- Scientific TitleThe effectiveness of using plantar pressure assessment and monitoring in prescription footwear to reduce re-ulceration rate in diabetic patients: A Randomized Controlled Trial.
- ACRONYMDIAFOS trial
- hypothesisTherapeutic 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) studiedDiabetes Mellitus
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-dec-2011
- Target number of participants240
- InterventionsTherapeutic (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 outcomeProportion of patients with a plantar diabetic foot ulcer within an 18-month follow-up period.
- Secondary outcome1. 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).
- TimepointsBaseline assessment;
Entry visit (0 months);
Follow-up visits each 3 months for 18 months
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD S.A. Bus
- CONTACT for SCIENTIFIC QUERIESPhD S.A. Bus
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe 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)
- RECORD15-okt-2007 - 20-mrt-2008


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