Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: removable walker; Device: cast shoe

• Registration Number: NCT03215953
• Lead Sponsor: Assiut University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Study Start: 2019-02-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Diabetes, loss of protective sensation, forefoot pressure ulcer

Read More

Exclusion Criteria

• Ankle/Brachial index less than 0.7, severe infection

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	removable walker	removable walker plus standard wound care
Group A	cast shoe	cast shoe plus standard wound care

Primary Outcome Measures

Name	Time	Method
Reduction of mean ulcer radius	6 months	Mean ulcer radius is √(area/π)
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Asyut, Egypt