To assess the cost-effectiveness and cost-utility of at-home foot temperature monitoring to reduce incidence of foot ulcer recurrence in patients with diabetes. Main research questions:1. What is the cost-effectiveness of enhanced therapy in…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Costs per patient without a foot ulcer and per quality adjusted life year.
- The proportion of patients with a foot ulcer recurrence during 18-month
follow-up.
Secondary outcome
- Costs of advanced therapy and ulcer treatment.
- Adherence to at-home foot temperature monitoring.
- Health-related quality of life.
Background summary
To prevent foot ulcer recurrence in diabetes, guidelines recommend protective
pressure-relieving footwear, in addition to patient and family education,
regular foot screening and preventative foot care. Despite these guidelines,
risk of ulcer recurrence in patients after and episode of ulceration remains
high, up to 40% in one year. Therefore, care providers and patients are in need
of adjunctive ways to prevent ulcer recurrence. At-home monitoring of foot
temperature shows promising results. Ulcers are preceded by increased local
skin temperature due to inflammation and enzymatic autolysis of tissue as a
result of being ambulatory. These increased temperatures can be easily assessed
by patients using at-home monitoring of foot temperature. Timely identification
of these areas allows the patient or care provider to take action to decrease
the inflammation before an ulcer develops, for example by reducing ambulatory
activity, and/or providing further offloading with footwear, orthoses or felted
foam. Research in the US has shown that monitoring the foot temperature on a
daily basis significantly reduced the risk ulcer recurrence. However, we do
not know whether this applies to other settings and what the cost-effectiveness
and cost-utility is of the intervention. Furthermore, the approach is not yet
implemented in foot care.
Study objective
To assess the cost-effectiveness and cost-utility of at-home foot temperature
monitoring to reduce incidence of foot ulcer recurrence in patients with
diabetes.
Main research questions:
1. What is the cost-effectiveness of enhanced therapy in preventing foot ulcer
recurrence in diabetic patients?
2. What is the cost-utility of enhanced therapy in preventing foot ulcer
recurrence in diabetic patients?
3. What is the effectiveness of enhanced therapy (i.e. usual care + at-home
foot temperature monitoring) in comparison with usual care only on foot ulcer
recurrence in diabeticp patients?
4. What is the adherence to at-home foot temperature monitoring in at-risk
diabetic patients?
Study design
Multicenter single-blinded randomized controlled trial of two study amrs in a
balanced design, with primary outcome assessors blinded to treatment allocation
and patient follow-up of 18 months.
Intervention
the intervention is usual care added with at-home daily measurement of foot
temperatures at 6 predefined locations on both feet. If foot temperature is
increased on 2 consecutive days, the patient is instructed to contact the
podiatrist, possibly for further foot diagnosis, and to reduce ambulatory
activity with 50% until temperatures are normalized.
The intervention will be compared to usual care that generally consists of:
therapeutic footwear, patient education, and once every 1-3 months foot
screening and care by the podiatrist/ diabetes pedicure.
Study burden and risks
The burden is that patients in the intervention group are required to measure
on a daily basis the skin temperature in their feet, as explaied above. The
risks associated with the study are low. There is no known risk of at-home
monitoring of the foot temperature.
Laan van Nieuw Oost-Indie 334
Den Haag 2593 CE
NL
Laan van Nieuw Oost-Indie 334
Den Haag 2593 CE
NL
Listed location countries
Age
Inclusion criteria
1. Diabetes mellitus;
2. Age 18 or above;
3. Peripheral neuropathy;
4. Recent history of a foot ulcer or foot amputation, i.e. an ulcer has been present for at least 2 weeks and has healed within four years before randomization, or a diagnosis of midfoot or forefoot Charcot neuro-osteoarthropathy;
5. Ability to provide informed consent;
6. Ambulatory status (i.e. not permanently wheel-chair bound).
7. The patient is treated by a podiatrist or is willing to undergo treatment by a podiatrist from the study.
Exclusion criteria
1. Active foot ulceration or open amputation sites.
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 both feet.
5. Severe illness that would make 18-months survival unlikely, based on the clinical judgment by the physician
6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on the clinical judgment by the physician. This includes the inability to perform temperature measurements, without having a caretaker who can perform the temperature measurements.
7. Current use of home-monitoring of foot temperature.
8. Critical limb ischemia, based on criteria of the PEDIS classification
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52735.018.15 |
| OMON | NL-OMON25946 |