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D-FAR is to gather robust data on the clinical characteristics, management, and outcomes of patients with diabetic foot complications to enhance understanding, reduce complications, and improve patient care. This will include insights into the prevalence of risk factors, adherence to treatment protocols, and the effectiveness of interventions aimed at reducing the incidence of amputations and other adverse outcomes.
Among the various complications, those related to diabetic foot disease are associated with the highest morbidity and mortality. Diabetic foot problems are characterized by infection, ulceration and/or destruction of deep tissue in the foot and are usually associated with neurological abnormalities and varying degrees of peripheral arterial disease (PAD) in the lower limb. the purpose of collect comprehensive data on the clinical features, management strategies, and outcomes of patients with diabetic foot complications.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Complete Wound Healing | Percentage of patients with diabetic foot ulcers who achieve complete wound closure without discharge or infection as recorded during follow-up visits. Defined as complete epithelialization of the diabetic foot ulcer with no discharge or infection as assessed during clinical follow-up. | Assessed at 3, 6, and 12 months post-enrollment |
| Proportion of Subjects Undergoing Amputation Due to Diabetic Foot Ulcer | Number of subjects requiring surgical amputation (minor or major) of the affected foot during the follow-up period | Up to 12 months from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken for Diabetic Foot Ulcer to Heal | Duration (in days) from initial presentation to confirmed complete healing of the ulcer. | Up to 12 months from enrollment |
| Change in SINBAD Score Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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African population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Nabeed Tahir, MBBS | Contact | +9230153762 | 2907 | nabeedtahir@getzpharma.com |
| Arsalan arif, MBBS | Contact | +923120279179 | arsalan.arif@getzpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Zulfiqarali G Abbas, MBBS, MMed, DTM&H | D-Foot International | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34838640 | Background | Abbas ZG, Boulton AJM. Diabetic foot ulcer disease in African continent: 'From clinical care to implementation' - Review of diabetic foot in last 60 years - 1960 to 2020. Diabetes Res Clin Pract. 2022 Jan;183:109155. doi: 10.1016/j.diabres.2021.109155. Epub 2021 Nov 24. | |
| 32371531 | Background | Naemi R, Chockalingam N, Lutale JK, Abbas ZG. Predicting the risk of future diabetic foot ulcer occurrence: a prospective cohort study of patients with diabetes in Tanzania. BMJ Open Diabetes Res Care. 2020 May;8(1):e001122. doi: 10.1136/bmjdrc-2019-001122. |
| Label | URL |
|---|---|
| ocuses on strategies to prevent foot ulcers, including patient education, regular foot examinations, and appropriate footwear.Provides recommendations on relieving pressure (offloading) from foot ulcers to promote healing. | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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SINBAD scores will be measured at baseline and during follow-up to assess changes in wound severity.
SINBAD is an acronym based on six parameters (Site, Ischemia, Neuropathy, Bacterial infection, Area, and Depth) Scale Range: 0 to 6 Directionality: Higher scores indicate worse outcomes (i.e., more severe diabetic foot ulcer characteristics and higher risk of complications such as non-healing, infection, amputation, or death).
Interpretation:
0-1: Mild ulcer, lower risk
2-3: Moderate ulcer, intermediate risk
4-6: Severe ulcer, high risk
| Baseline, 3, 6, and 12 months |
| All-Cause Mortality Among Subjects with Diabetic Foot Ulcers | Number and percentage of subjects who expire during the study period, regardless of cause. | Up to 12 months from enrollment |
| Proportion of Subjects with Peripheral Neuropathy and Peripheral Arterial Disease | Presence of peripheral neuropathy and peripheral arterial disease (PAD) in subjects with diabetic foot ulcers based on clinical exam.Can be determined by clinical signs such as loss of protective sensation, absence of pedal pulses, decrease vascularity | At baseline |
| 32770407 | Background | Bak JCG, Serne EH, Kramer MHH, Nieuwdorp M, Verheugt CL. National diabetes registries: do they make a difference? Acta Diabetol. 2021 Mar;58(3):267-278. doi: 10.1007/s00592-020-01576-8. Epub 2020 Aug 8. |