Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Getz Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Male and female patients 2. Residents of participating African countries. 3. Diagnosed with diabetic foot complications (e.g., ulcers, gangrene, infection, ischemia). 4. Patients with a history of foot ulcers or amputations due to diabetes. 5. High-risk patients with peripheral neuropathy and/or peripheral arterial disease.
Exclusion criteria
1. Non-diabetic foot complications. 2. Acute traumatic injuries unrelated to diabetes. 3. Patients unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Complete Wound Healing | Assessed at 3, 6, and 12 months post-enrollment | 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. |
| Proportion of Subjects Undergoing Amputation Due to Diabetic Foot Ulcer | Up to 12 months from enrollment | Number of subjects requiring surgical amputation (minor or major) of the affected foot during the follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Taken for Diabetic Foot Ulcer to Heal | Up to 12 months from enrollment | Duration (in days) from initial presentation to confirmed complete healing of the ulcer. |
| Change in SINBAD Score Over Time | Baseline, 3, 6, and 12 months | 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 |
| All-Cause Mortality Among Subjects with Diabetic Foot Ulcers | Up to 12 months from enrollment | Number and percentage of subjects who expire during the study period, regardless of cause. |
| Proportion of Subjects with Peripheral Neuropathy and Peripheral Arterial Disease | At baseline | 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 |
Contacts
Primary ContactMuhammad Nabeed Tahir, MBBS
Backup ContactArsalan arif, MBBS
Outcome results
None listed