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Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cast shoe
removable walker
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring offloading, plantar pressure, Diabetic Foot Ulcer, removable offloading device, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetes, loss of protective sensation, forefoot pressure ulcer

Exclusion Criteria:

  • Ankle/Brachial index less than 0.7, severe infection

Sites / Locations

  • Assiut University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

cast shoe plus standard wound care

removable walker plus standard wound care

Outcomes

Primary Outcome Measures

Reduction of mean ulcer radius
Mean ulcer radius is √(area/π)
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
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

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2017
Last Updated
July 13, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03215953
Brief Title
Offloading Interventions for Diabetic Foot Problems in Upper Egypt
Official Title
Offloading Interventions for Diabetic Foot Problems in Upper Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
offloading, plantar pressure, Diabetic Foot Ulcer, removable offloading device, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
cast shoe plus standard wound care
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
removable walker plus standard wound care
Intervention Type
Device
Intervention Name(s)
cast shoe
Intervention Description
ankle-high, custom-made, well-moulded cast shoe
Intervention Type
Device
Intervention Name(s)
removable walker
Intervention Description
Prefabricated especially designed for relieving load on the foot
Primary Outcome Measure Information:
Title
Reduction of mean ulcer radius
Description
Mean ulcer radius is √(area/π)
Time Frame
6 months
Title
Non-severe adverse events related to use of offloading device
Description
abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed
Time Frame
6 months
Title
Severe adverse events related to use of offloading device
Description
new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adherence
Description
patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours
Time Frame
6 months
Title
Perception
Description
patient's own opinion regarding his overall appreciation as a visual analogue score
Time Frame
6 months
Title
severity of pain
Description
patient's own opinion regarding pain as a visual analogue score
Time Frame
6 months
Title
Mobility
Description
patient's own opinion regarding limitation of mobility as visual analogue score
Time Frame
6 months
Title
Lifestyle limitation
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes, loss of protective sensation, forefoot pressure ulcer Exclusion Criteria: Ankle/Brachial index less than 0.7, severe infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad HM AbdEllah, MSc
Phone
+201115353591
Email
mhmdifferent@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa A Khalifa, MD
Phone
+201111677728
Email
dr.walaaanwar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walaa A Khalifa, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Asyut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad HM AbdEllah, Specialist
Phone
+201115353591
Email
mhmdifferent@gmail.com
First Name & Middle Initial & Last Name & Degree
Walaa A Khalifa, Consultant
First Name & Middle Initial & Last Name & Degree
Mohammad HM AbdEllah, specialist

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26813614
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.
Results Reference
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Offloading Interventions for Diabetic Foot Problems in Upper Egypt

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