Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Study Overview
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Brief Summary
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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
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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.

Official Title
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Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: cast shoe
* Device: removable walker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes, loss of protective sensation, forefoot pressure ulcer Exclusion Criteria: Ankle/Brachial index less than 0.7, severe infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>cast shoe plus standard wound care | Device: cast shoe<br>* ankle-high, custom-made, well-moulded cast shoe<br>|
| Active Comparator: Group B<br>removable walker plus standard wound care | Device: removable walker<br>* Prefabricated especially designed for relieving load on the foot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of mean ulcer radius | Mean ulcer radius is √(area/π) | 6 months | 
| Non-severe adverse events related to use of offloading device | abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed | 6 months | 
| Severe adverse events related to use of offloading device | new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours | 6 months | 
| Perception | patient's own opinion regarding his overall appreciation as a visual analogue score | 6 months | 
| severity of pain | patient's own opinion regarding pain as a visual analogue score | 6 months | 
| Mobility | patient's own opinion regarding limitation of mobility as visual analogue score | 6 months | 
| Lifestyle limitation | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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offloading, plantar pressure, Diabetic Foot Ulcer, removable offloading device, adherence