Offloading Interventions for Diabetic Foot Problems in Upper Egypt

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: cast shoe; Device: removable walker

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Recruiting
    • Assiut University Hospital
    • Contact: Mohammad HM AbdEllah, Specialist; Phone Number: +201115353591; Email: mhmdifferent@gmail.com
    • Contact: Walaa A Khalifa, Consultant
    • Principal Investigator: Mohammad HM AbdEllah, specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes, loss of protective sensation, forefoot pressure ulcer

Exclusion Criteria:

• Ankle/Brachial index less than 0.7, severe infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Walaa A Khalifa, MD, Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: adherence; Diabetic Foot Ulcer; plantar pressure; offloading; removable offloading device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: OIDFUE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No