Diabetes Foot Africa Region Registry

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female patients
Residents of participating African countries.
Diagnosed with diabetic foot complications (e.g., ulcers, gangrene, infection, ischemia).
Patients with a history of foot ulcers or amputations due to diabetes.
High-risk patients with peripheral neuropathy and/or peripheral arterial disease.

Exclusion criteria

Non-diabetic foot complications.
Acute traumatic injuries unrelated to diabetes.
Patients unwilling to provide informed consent.

Treatment and study plan

Primary outcomes

Proportion of Subjects Achieving Complete Wound Healing

Time frame: 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

Time frame: 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 outcomes

Time Taken for Diabetic Foot Ulcer to Heal

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Arsalan arif, MBBS

CONTACT

[email protected]

+923120279179

Muhammad Nabeed Tahir, MBBS

CONTACT

[email protected]

+9230153762 ext. 2907

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Registry information

Acronym: (D-FAR)

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 22, 2025
Registry last updated: Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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