Offloading Interventions for Diabetic Foot Problems in Upper Egypt
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|ClinicalTrials.gov Identifier: NCT03215953|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Device: cast shoe Device: forefoot offloading shoe||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Reduction of mean ulcer radius [ Time Frame: 6 months ]Mean ulcer radius is √(area/π)
- new ulcer [ Time Frame: 6 months ]development of new ulcer at a different site during the study course
- acute Charcot episode [ Time Frame: 6 months ]development of a confirmed neuropathic arthritis during the study course
- infection [ Time Frame: 6 months ]development of wound infection after enrollment in the study
- falls [ Time Frame: 6 months ]the patient reporting falling due to the offloading device
- abrasions [ Time Frame: 6 months ]Skin abrasions related to the offloading device
- amputation [ Time Frame: 6 months ]any type of amputation that occurs after enrollment in the study
- 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
- Perception [ Time Frame: 6 months ]patient's own opinion regarding his overall appreciation as a visual analogue score
- Pain [ Time Frame: 6 months ]patient's own opinion regarding pain as a visual analogue score
- Mobility [ Time Frame: 6 months ]patient's own opinion regarding limitation of mobility as visual analogue score
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03215953
|Contact: Mohammad HM AbdEllah, MScfirstname.lastname@example.org|
|Contact: Walaa A Khalifa, MDemail@example.com|
|Principal Investigator:||Walaa A Khalifa, MD||Assiut University|