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Diabetes Foot Africa Region Registry

ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGetz Pharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-diabetic foot complications.

Acute traumatic injuries unrelated to diabetes.

Patients unwilling to provide informed consent.

Trial population

African population

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at 3, 6, and 12 months post-enrollment
2

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

Time frame
Up to 12 months from enrollment

Secondary outcomes

1

Time Taken for Diabetic Foot Ulcer to Heal

Duration (in days) from initial presentation to confirmed complete healing of the ulcer.

Time frame
Up to 12 months from enrollment
2

Change in SINBAD Score Over Time

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

Time frame
Baseline, 3, 6, and 12 months
3

All-Cause Mortality Among Subjects with Diabetic Foot Ulcers

Number and percentage of subjects who expire during the study period, regardless of cause.

Time frame
Up to 12 months from enrollment
4

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

Time frame
At baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Getz Pharma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: