|- candidate number||22846|
|- NTR Number||NTR5403|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-sep-2015|
|- Secondary IDs||NL52735.018.15 |
|- Public Title||The cost-effectiveness and cost-utility of monitoring foot temperature at home to prevent foot ulcer recurrence in patients with diabetes|
|- Scientific Title||The cost-effectiveness and cost-utility of at-home infrared temperature monitoring in reducing the incidence of foot ulcer recurrence in patients with diabetes|
|- hypothesis||At-home infrared temperature monitoring of the foot in addition to usual care, is cost-effective and saves costs per quality adjusted life year gained in the prevention of foot ulcer recurrence in patients with diabetes, compared to usual care alone |
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus, diabetic ulcer, Diabetic foot|
|- Inclusion criteria||1. Diabetes mellitus type 1 or 2;|
2. Age 18 or above;
3. Loss of protective sensation based on the presence of peripheral neuropathy;
4. Recent history of a foot ulcer or foot amputation (preceding 2 years)
5. Ability to provide informed consent
6. Ambulatory status
|- Exclusion criteria||1. Active foot ulceration or open amputation site|
2. Active Charcot neuro-osteo arthropathy.
3. Active foot infection, based on criteria of the PEDIS classification
4. Amputation proximal to the Chopart joint in boot feet
5. Critical limb ischemia (according to PEDIS classification)
5. Severe illness that would make 18-months survival unlikely, based on the clinical judgement by the physician or podiatrist.
6. Concomitant severe physical or mental conditions that limit the ability to follow the instructions for the study, based on the clinical judgment by the physician or podiatrist.
7. Current use of home-monitoring of foot temperature.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2015|
|- planned closingdate||30-sep-2018|
|- Target number of participants||304|
|- Interventions||The intervention consists of usual care added with at-home daily measurement of foot temperature at 6 predefined locations on both feet + max 1 or 2 locations based on ulcer history or pre-ulcer status, if different than predefined locations. If foot temperature is abnormal (i.e. >2.2 degrees celcius between same locations on both feet) on 2 consecutive days, the patient is instructed to contact the podiatrist, possibly for further foot diagnosis, and to reduce ambulatory activity until temperatures are normalized.
Usual care consists of: once every 1-3 months foot screening and/or foot care by a fot care specialist, patient education, and, if indicated, therapeutic footwear
|- Primary outcome||- The proportion of patients with a foot ulcer recurrence on the plantar foot or medial and lateral forefoot surface during 18 months follow-up |
- Cost (savings) per patient without a recurrent foot ulcer and per quality adjusted life year
|- Secondary outcome||- Costs of advanced therapy and ulcer treatment|
- Adherence to at-home temperature monitoring
- In-shoe dynamic plantar pressure
- Barefoot dynamic plantar pressure
- Number of steps per day (daily ambulatory activity level)
- Footwear use
- Adverse events
- Quality of life
|- Timepoints||1. 0 months: Baseline screening assessment: medical history and physical assessment, randomization, study instructions|
2. Within 3 months after baseline: Biomechanical and activity assessment: barefoot and in-shoe pressure measurement, one-week activity and adherence monitoring.
3. Every three months: Proces monitoring for primary outcome and medical consumption, cost-data, and quality of life.
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||PhD S.A. Bus|
|- CONTACT for SCIENTIFIC QUERIES||PhD S.A. Bus|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Dutch Society for Podiatrists, ProVoet, branche organisation for pedicures|
|- Brief summary||In diabetic foot practice it proves difficult to prevent foot ulcer recurrence in patients with diabetes mellitus. Care providers and patients are in need of adjunctive ways to prevent foot ulcer recurrence. The home monitoring of foot temperatures, for early recognition and treatment of pre-signs of ulceration proves to be a promising approach. Despite that previous studies demonstrated the efficacy of the intervention, it is currently not (widely) applied in preventative foot care. Data that confirm earlier findings, data on cost-effectiveness and utility, and implementability are lacking. |
This multicenter single-blinded randomized controlled trial with a patient follow-up of 18 months aims to assess the cost-effectiveness and cost-utility of at-home foot temperature monitoring to reduce the incidence of foot ulcer recurrence in patients with diabetes mellitus, in comparison to usual care.
|- Main changes (audit trail)|
|- RECORD||8-sep-2015 - 21-okt-2015|