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Not yet recruiting NCT07031141

Diabetes Foot Africa Region Registry

— Observational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetes. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Proportion of Subjects Achieving Complete Wound Healing [Time frame: Assessed at 3, 6, and 12 months post-enrollment]
  • Proportion of Subjects Undergoing Amputation Due to Diabetic Foot Ulcer [Time frame: Up to 12 months from enrollment]
Secondary outcome measures (4)
  • Time Taken for Diabetic Foot Ulcer to Heal [Time frame: Up to 12 months from enrollment]
  • Change in SINBAD Score Over Time [Time frame: Baseline, 3, 6, and 12 months]
  • All-Cause Mortality Among Subjects with Diabetic Foot Ulcers [Time frame: Up to 12 months from enrollment]
  • Proportion of Subjects with Peripheral Neuropathy and Peripheral Arterial Disease [Time frame: At baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 34838640
  • 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. PMID 32371531
  • 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. PMID 32770407

Identifiers

NCT: NCT07031141 · GETZ-DF-01-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗