Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Diabetic Foot Ulcer Clinical Trial

Official title:

Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215953
• Other study ID #: OIDFUE001
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: Mohammad HM AbdEllah, MSc
• Phone: +201115353591
• Email: mhmdifferent[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes, loss of protective sensation, forefoot pressure ulcer

Exclusion Criteria:

• Ankle/Brachial index less than 0.7, severe infection

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• cast shoe
ankle-high, custom-made, well-moulded cast shoe
• removable walker
Prefabricated especially designed for relieving load on the foot

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of mean ulcer radius	Mean ulcer radius is v(area/p)	6 months
Primary	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
Primary	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	Adherence	patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours	6 months
Secondary	Perception	patient's own opinion regarding his overall appreciation as a visual analogue score	6 months
Secondary	severity of pain	patient's own opinion regarding pain as a visual analogue score	6 months
Secondary	Mobility	patient's own opinion regarding limitation of mobility as visual analogue score	6 months
Secondary	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