Offloading Interventions for Diabetic Foot Problems in Upper Egypt

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03215953
Recruitment Status : Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):
Mohammad Hasan AbdEllah, 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 forefoot offloading shoe considering effectiveness, complications, compliance and patient's appreciation.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: cast shoe Device: forefoot offloading shoe Not Applicable

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.

In Upper Egypt, 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 forefoot offloading shoe, as different offloading options to cure diabetic foot ulcers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Offloading Interventions for Diabetic Foot Problems in Upper Egypt
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

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
forefoot offloading shoe plus standard wound care
Device: forefoot offloading shoe
Prefabricated shoe especially designed for relieving forefoot locations on the foot

Primary Outcome Measures :
  1. Reduction of mean ulcer radius [ Time Frame: 6 months ]
    Mean ulcer radius is √(area/π)

Secondary Outcome Measures :
  1. new ulcer [ Time Frame: 6 months ]
    development of new ulcer at a different site during the study course

  2. acute Charcot episode [ Time Frame: 6 months ]
    development of a confirmed neuropathic arthritis during the study course

  3. infection [ Time Frame: 6 months ]
    development of wound infection after enrollment in the study

  4. falls [ Time Frame: 6 months ]
    the patient reporting falling due to the offloading device

  5. abrasions [ Time Frame: 6 months ]
    Skin abrasions related to the offloading device

  6. amputation [ Time Frame: 6 months ]
    any type of amputation that occurs after enrollment in the study

  7. Adherence [ Time Frame: 6 months ]
    patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours

  8. Perception [ Time Frame: 6 months ]
    patient's own opinion regarding his overall appreciation as a visual analogue score

  9. Pain [ Time Frame: 6 months ]
    patient's own opinion regarding pain as a visual analogue score

  10. Mobility [ Time Frame: 6 months ]
    patient's own opinion regarding limitation of mobility as visual analogue score

  11. Lifestyle limitation [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetes, loss of protective sensation, forefoot pressure ulcer

Exclusion Criteria:

  • Ankle/Brachial index less than 0.7, severe infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03215953

Contact: Mohammad HM AbdEllah, MSc +201115353591
Contact: Walaa A Khalifa, MD +201111677728

Sponsors and Collaborators
Assiut University
Principal Investigator: Walaa A Khalifa, MD Assiut University

Responsible Party: Mohammad Hasan AbdEllah, Principal Investigator, Assiut University Identifier: NCT03215953     History of Changes
Other Study ID Numbers: OIDFUE001
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Mohammad Hasan AbdEllah, Assiut University:
plantar pressure
Diabetic Foot Ulcer
cast shoe
forefoot offloading shoe

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases