Primary objective: Investigation of mean peak plantar pressure at the location of the diabetic foot ulcer and at 6 plantar regions of the foot (i.e. hallux, digits, first metatarsal, second to fifth metatarsals, midfoot, and heel) during total…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
- Skin vascular abnormalities
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peak plantar pressure during a minimum of 12 midgait steps with the affected
foot
Secondary outcome
Patient comfort, expressed using a visual analoge scale.
Background summary
Diabetic foot ulcers are a major health problem. Adequate offloading is
paramount for the treatment of diabetic foot ulcers. Irremovable, knee-high
total contact casts are recommended for plantar diabetic foot ulcers on the
forefoot or midfoot. However, these are infrequently used due to poor patient
acceptance because of negative impacts on lifestyle and mobility. Recently,
several hospitals in the Netherlands have used non-rigid cast materials for
offloading cast treatments, named 'total contact softcast offloading'. The key
difference with conventional total contact cast offloading is that total
contact softcast offloading allows some mobility of the ankle which could
reduce the negative impacts on lifestyle and mobility. In clinical practice,
good experiences have been reported. But total contact softcast offloading has
practically not been investigated. Therefore, we designed a cross-over
observational pilot study to investigate peak plantar pressure and patient
comfort. Our hypothesis is that mean peak pressure at the diabetic foot ulcer
is lower during total contact softcast offloading than it is during
mobilization in the patient*s own footwear. We expect that this reduction in
mean peak pressure is non-inferior to the reduction found during total contact
cast offloading.
Study objective
Primary objective: Investigation of mean peak plantar pressure at the location
of the diabetic foot ulcer and at 6 plantar regions of the foot (i.e. hallux,
digits, first metatarsal, second to fifth metatarsals, midfoot, and heel)
during total contact softcast offloading, conventional total contact cast
offloading and whilst wearing own footwear.
Secondary objectives:
1) Investigation of mean peak plantar pressure at 6 plantar regions of the foot
(i.e. hallux, digits, first metatarsal, second to fifth metatarsals, midfoot,
and heel) during total contact softcast offloading, conventional total contact
cast offloading and whilst wearing own footwear.
2) Investigation of patient comfort during total contact softcast offloading,
conventional total contact cast offloading and whilst wearing own footwear
using a Visual Analogue Scale.
Study design
Cross-over observational study pilot.
Study burden and risks
We will perform the study procedures at a single session during a clinical
visit 1-8 weeks after the start of the casting treatment, which will require
approximately 90 minutes in addition to the time needed for cast replacement as
part of the standard treatment. We will assess peak plantar pressure on a
non-invasive manner using an insole with pressure sensors, and patient comfort
as a patient-reported outcome measure. The risks of these study procedures are
negligible, since casts are applied once for approximately 20 minutes, and
mobilization whilst wearing the casts is supervised by medical personnel.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1) Age 18 years or older
2) Diagnosed with diabetes mellitus
3) A plantar diabetic foot ulcer on the forefoot or midfoot for which
offloading by total contact softcast or total contact cast is indicated
Exclusion criteria
1) Inability or unwillingness to provide a written declaration of informed
consent.
2) Unable to mobilize weight-bearing
3) moderate or severe diabetic foot infection, as defined by the international
working group on the diabetic foot / infectous diseases society of America
(IWGDF / IDSA).
4) Moderate or severe limb ischemia, as defined in the Wound, Ischemia, foot
Infection (WIfI) classification.
5) The combination of mild limb ischemia and mild infection, defined in
accordance with the WIfI classification and IWGDF / IDSA definitions,
respectively.
6) Severe foot deformities (e.g. Charcot neuroarthropathy-related deformity,
ankle arthrodesis, partial calcanectomy) which lead to increased pressure and
friction on the site of the DFU and thereby make adequate TCSO or TCCO
impossible, as judged clinically by the treating physician
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77689.042.21 |