Diabetic Foot Ulcer
Conditions
Keywords
offloading, plantar pressure, Diabetic Foot Ulcer, removable offloading device, adherence
Brief summary
Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. Many forms of offloading are available, with many limitations to apply in clinical practice. In this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.
Detailed description
Abnormal glucose metabolism gradually impairs sensation in both feet. Impaired sensation leads to recurrent attacks of inflammation acute Charcot arthritis. Eventually, the foot becomes deformed with abnormal shape of the plantar surface. During walking, both neuropathy and deformities cause abnormal distribution of pressure with some points in the plantar surface having a very high pressure. This high pressure leads to skin ulceration pressure ulcer. These pressure ulcers tend to be recurrent or chronic as long as the problem of high pressure is not resolved. Offloading techniques are pressure-relieving interventions that redistribute body weight over the plantar surface. Areas with high pressure which are at high risk of ulceration, are treated to decrease pressure and cure ulcers. The diabetic foot clinic at Assiut university hospital provides patients with necessary care to avoid the single most fearsome enemy, amputation. This clinic currently provides many offloading options based on expert opinion, and there is an urgent need to have a well-balanced view supported by evidence, considering both the physician and the patient. The investigators' project is to conduct a series of trials to guide policies concerned with diabetic foot problems, OIDFUA. This study will compare cast shoe with removable walker, as different offloading options to cure diabetic foot ulcers.
Interventions
DEVICEcast shoe
ankle-high, custom-made, well-moulded cast shoe
DEVICEremovable walker
Prefabricated especially designed for relieving load on the foot
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetes, loss of protective sensation, forefoot pressure ulcer
Exclusion criteria
* Ankle/Brachial index less than 0.7, severe infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of mean ulcer radius | 6 months | Mean ulcer radius is √(area/π) |
| Non-severe adverse events related to use of offloading device | 6 months | abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed |
| Severe adverse events related to use of offloading device | 6 months | new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility | 6 months | patient's own opinion regarding limitation of mobility as visual analogue score |
| Adherence | 6 months | patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours |
| Lifestyle limitation | 6 months | patient's own opinion regarding how far the device interferes with his daily activities by naming the activities that needed more effort, e.g. bathing, or stopped, e.g. going to work. |
| Perception | 6 months | patient's own opinion regarding his overall appreciation as a visual analogue score |
| severity of pain | 6 months | patient's own opinion regarding pain as a visual analogue score |
Countries
Egypt
Contacts
Primary ContactMohammad HM AbdEllah, MSc
Backup ContactWalaa A Khalifa, MD
Outcome results
None listed