Diabetes Foot Africa Region Registry

NCT07031141 | Not Yet Recruiting

• 1 other identifier: GETZ-DF-01-24
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Up to 12 months from enrollment

Secondary Outcomes (4)

• Time Taken for Diabetic Foot Ulcer to Heal

  Up to 12 months from enrollment

• Change in SINBAD Score Over Time

  Baseline, 3, 6, and 12 months

• All-Cause Mortality Among Subjects with Diabetic Foot Ulcers

  Up to 12 months from enrollment

• Proportion of Subjects with Peripheral Neuropathy and Peripheral Arterial Disease

  At baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

African population

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Getz Pharma: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• ocuses on strategies to prevent foot ulcers, including patient education, regular foot examinations, and appropriate footwear.Provides recommendations on relieving pressure (offloading) from foot ulcers to promote healing.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zulfiqarali G Abbas, MBBS, MMed, DTM&H

  D-Foot International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Nabeed Tahir, MBBS

CONTACT

+9230153762; nabeedtahir@getzpharma.com

Arsalan arif, MBBS

CONTACT

+923120279179; arsalan.arif@getzpharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: June 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share