Diabetes(D-FAR)NCT07031141
Diabetes Foot Africa Region Registry
An observational study of Diabetes, run by Getz Pharma.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: African population
Who may be able to join
- 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.
Who cannot join
- Non-diabetic foot complications.
- Acute traumatic injuries unrelated to diabetes.
- Patients unwilling to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 12 months from enrollment
Secondary outcomes (4)
Time Taken for Diabetic Foot Ulcer to Heal
Duration (in days) from initial presentation to confirmed complete healing of the ulcer.
Measured: 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
Measured: 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.
Measured: 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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zulfiqarali G Abbas, MBBS, MMed, DTM&H, Principal investigator, D-Foot International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031141
- Sponsor's protocol ID
- GETZ-DF-01-24
- Acronym
- (D-FAR)
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34838640Naemi 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.
PubMed 32371531Bak 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.
PubMed 32770407
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Foot Africa Region Registry
- ClinicalTrials.gov ID
- NCT07031141
- Acronym / sponsor ID
- (D-FAR) / GETZ-DF-01-24
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- African population
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Non-diabetic foot complications.
- Acute traumatic injuries unrelated to diabetes.
- Patients unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 34838640Abbas 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.
- Background: PubMed 32371531Naemi 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.
- Background: PubMed 32770407Bak 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zulfiqarali G Abbas, MBBS, MMed, DTM&H principal investigator
D-Foot International
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Getz Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Nabeed Tahir, MBBS (+9230153762 ext. 2907, nabeedtahir@getzpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Achieving Complete Wound Healing (time frame: Assessed at 3, 6, and 12 months post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031141, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.