Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | cast shoe plus standard wound care |
|
| Group B | Active Comparator | removable walker plus standard wound care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cast shoe | Device | ankle-high, custom-made, well-moulded cast shoe |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad HM AbdEllah, MSc | Contact | +201115353591 | mhmdifferent@gmail.com | |
| Walaa A Khalifa, MD | Contact | +201111677728 | dr.walaaanwar@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Walaa A Khalifa, MD | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University Hospital | Recruiting | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26813614 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| removable walker |
| Device |
Prefabricated especially designed for relieving load on the foot |
|
| 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 |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |