Clinical trial NCT03215953: Offloading Interventions for Diabetic Foot Problems in Upper Egypt
Official title: Offloading Interventions for Diabetic Foot Problems in Upper Egypt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: offloading
plantar pressure
Diabetic Foot Ulcer
removable offloading device
adherence
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diabetes, loss of protective sensation, forefoot pressure ulcer

Exclusion Criteria:

* Ankle/Brachial index less than 0.7, severe infection

Primary outcomes:
measure: Reduction of mean ulcer radius
timeFrame: 6 months
measure: Non-severe adverse events related to use of offloading device
timeFrame: 6 months
measure: Severe adverse events related to use of offloading device
timeFrame: 6 months
Secondary outcomes:
measure: Adherence
timeFrame: 6 months
measure: Perception
timeFrame: 6 months
measure: severity of pain
timeFrame: 6 months
measure: Mobility
timeFrame: 6 months
measure: Lifestyle limitation
timeFrame: 6 months
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Walaa A Khalifa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bus SA, Armstrong DG, van Deursen RW, Lewis JE, Caravaggi CF, Cavanagh PR; International Working Group on the Diabetic Foot. IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:25-36. doi: 10.1002/dmrr.2697. No abstract available.