An observational study in Diabetes, sponsored by Getz Pharma. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Getz Pharma · Observational
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Getz Pharma is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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African population
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Getz Pharma