Limb SalvageNCT07442110
This Observational Study Evaluates the Clinical Outcomes of Patients With Diabetes Who Utilize a Specialized Dietary Supplements for Foot Ulcer Healing. The Study Documents the Rate of Complete Wound Closure and the Prevention of Lower Extremity Amputations in a Real-world, At-home Setting.
An observational study of Limb Salvage and Diabetes Complication, run by Amar h Zireg at 1 site in Algeria.
Trial summary
This observational study evaluates the clinical outcomes of patients with diabetes who utilize a specialized dietary supplements for foot ulcer healing. The study documents the rate of complete wound closure and the prevention of lower extremity amputations in a real-world, at-home setting. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Limb Salvage, Diabetes Complication, Dietary Supplements
- What is being tested?
- Diabetic foot ulcer treatment by dietary supplements
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- 1 siteAlgeria
- Study dates
- 5 Jul 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 35 adult patients (both male and female) diagnosed with Type 1 or Type 2 Diabetes Mellitus who present with chronic, unhealed diabetic foot ulcers (Wagner Stages 1 to 5). This group includes high-risk individuals who have previously undergone minor amputations (e.g., toe/digit) or were clinically scheduled for lower extremity amputations due to failed standard wound care. The participants are observed in an at-home setting, where they self-administer the specialized dietary supplement protocol.
Who may be able to join
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus. Presence of at least one chronic diabetic foot ulcer (DFU) classified as Wagner Grade 1 to 5.
- Patients currently facing potential lower extremity amputation as recommended by a surgical consultation.
- Patients currently adhering to the specific dietary supplements protocol for wound healing.
- Ability to participate in a 6-week clinical observation period with weekly monitoring.
- Age 18 years and older.
- Exclusion Criteria Patients with non-diabetic ulcers (e.g., pressure sores not related to diabetes or purely venous stasis ulcers).
- Pregnancy or breastfeeding.
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Algeria1 site
Amar hocine Zireg
Bordj Bou Arreridj, Wilaya de Bordj Bou Arréridj, 34000
About this study
Official title: Observational Study of a Specialized Dietary Supplements on the Healing of Diabetic Foot Ulcers and Prevention of Amputations
This observational study evaluates the clinical outcomes of patients with diabetes who utilize a specialized dietary supplements for foot ulcer healing. The study documents the rate of complete wound closure and the prevention of lower extremity amputations in a real-world, at-home setting.
Read the detailed description
Context: Observation of patients with chronic diabetes mellitus and foot ulcers (Wagner stages 1-5).
Observation: Data collection on the administration of daily nutritional supplements.
Assessment: Weekly monitoring of tissue viability ( granulation tissue growth), reduction in inflammation, and drainage.
Observed Outcomes: Documentation of complete healing rates and limb salvage in high-risk cases where amputation was previously indicated
- Conditions
- Limb Salvage, Diabetes Complication, Dietary Supplements, Healed Ulcer, Wound Closure, At Home Setting
- Being tested
- Diabetic foot ulcer treatment by dietary supplements
- Keywords
- Diabetes, limb-salvage, Diabetic foot ulcer, wound closure, complete wound closure, dietary supplements, Type1&2 Diabetes, Complete Wound Closure (CWC), Metabolic Restoration, Wagner Grade 5, Surgical Avoidance, Amputation-Free Survival (AFS)
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic foot ulcer treatment by dietary supplementsDietary supplement
Intervention Type: Dietary Supplement Intervention Name: Diabetic Foot Ulcer Nutritional Protocol
Description:
A specific regimen of daily dietary supplements designed to support metabolic health and accelerated tissue repair in diabetic patients.
The protocol involves the administration of targeted nutrients known to enhance collagen synthesis, reduce systemic inflammation.Participants consume the supplements orally on a daily basis over a 6-week period.
The observation focuses on the supplement's ability to facilitate complete wound closure (epithelialization) and salvage limbs in patients previously scheduled for amputation.
Study Status: Completed (s
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplements | Patients with Type 1 and 2 diabetes self-administering or prescribed a specific dietary supplements for wound care.
Intervention (Observed):
Type: Dietary Supplements Name: Diabetic Foot Ulcer Nutritional Protocol Receives: Dietary Supplement: Diabetic foot ulcer treatment by dietary supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Wound Closure.
Measure Description: Percentage of participants achieving full epithelialization of the target ulcer, defined as the absence of drainage and no further requirement for clinical dressing.
Measured: 06 weeks
Rate of Complete Wound Closure
Outcome Measure Title: Rate of Complete Wound Closure Measure Description: Percentage of participants achieving full epithelialization of the target ulcer, defined as the absence of drainage and no further requirement for clinical dressing.
Time Frame: 6 weeks. Outcome Measure Title: Incidence of Lower Extremity Amputation Measure Description: Number of participants requiring minor (toe/transmetatarsal) or major (above/below-knee) amputations during the observation period.
Time Frame: Up to 6 weeks. Outcome Measure Title: Time to Complete Wound Closure Measure Description: Number of weeks required to reach full clinical healing (100% epithelialization) for participants achieving closure.
Time Frame: Weekly for up to 6 weeks. Outcome Measure Title: Change in Wound Surface Area Measure Description: Measurement of the variation in the ulcer's physical dimensions (length x width in millimeters) from baseline to the final assessment.
Measured: Baseline and 6 weeks.
Incidence of Lower Extremity Amputation.
Outcome Measure Title: Time to Complete Wound Closure Measure Description: Number of weeks required to reach full clinical healing (100% epithelialization) for participants achieving closure.
Time Frame: Weekly for up to 6 weeks. Outcome Measure Title: Change in Wound Surface Area Measure Description: Measurement of the variation in the ulcer's physical dimensions (length x width in millimeters) from baseline to the final assessment.
Measured: Up to 06 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start5 Jul 2025
- Primary completion2 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb SalvageStudies 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
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amar h Zireg
- Sponsor type
- University, hospital or other
- Collaborators
- Self funded
- Responsible party
- Sponsor-investigator, Amar h Zireg, Amar Zireg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442110
- Sponsor's protocol ID
- ZiregAmar
- Other IDs
- AZ-DFU-2025-06
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of a Specialized Dietary Supplements on the Healing of Diabetic Foot Ulcers and Prevention of Amputations
- ClinicalTrials.gov ID
- NCT07442110
- Acronym / sponsor ID
- ZiregAmar
- Conditions
- Limb Salvage, Diabetes Complication, Dietary Supplements, Healed Ulcer, Wound Closure, At Home Setting
- Keywords
- Diabetes, limb-salvage, Diabetic foot ulcer, wound closure, complete wound closure, dietary supplements, Type1&2 Diabetes, Complete Wound Closure (CWC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Amar h ZiregUniversity, hospital or other
- Collaborators
- Self funded
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 2 Mar 2026 (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.
This observational study evaluates the clinical outcomes of patients with diabetes who utilize a specialized dietary supplements for foot ulcer healing. The study documents the rate of complete wound closure and the prevention of lower extremity amputations in a real-world, at-home setting.
Detailed description
Context: Observation of patients with chronic diabetes mellitus and foot ulcers (Wagner stages 1-5).
Observation: Data collection on the administration of daily nutritional supplements.
Assessment: Weekly monitoring of tissue viability ( granulation tissue growth), reduction in inflammation, and drainage.
Observed Outcomes: Documentation of complete healing rates and limb salvage in high-risk cases where amputation was previously indicated
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplements | – | Dietary Supplement: Diabetic foot ulcer treatment by dietary supplementsPatients with Type 1 and 2 diabetes self-administering or prescribed a specific dietary supplements for wound care. Intervention (Observed): Type: Dietary Supplements Name: Diabetic Foot Ulcer Nutritional Protocol |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 35 adult patients (both male and female) diagnosed with Type 1 or Type 2 Diabetes Mellitus who present with chronic, unhealed diabetic foot ulcers (Wagner Stages 1 to 5). This group includes high-risk individuals who have previously undergone minor amputations (e.g., toe/digit) or were clinically scheduled for lower extremity amputations due to failed standard wound care. The participants are observed in an at-home setting, where they self-administer the specialized dietary supplement protocol.
Key inclusion criteria (7 listed)
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus. Presence of at least one chronic diabetic foot ulcer (DFU) classified as Wagner Grade 1 to 5.
- Patients currently facing potential lower extremity amputation as recommended by a surgical consultation.
- Patients currently adhering to the specific dietary supplements protocol for wound healing.
- Ability to participate in a 6-week clinical observation period with weekly monitoring.
- Age 18 years and older.
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic foot ulcer treatment by dietary supplementsIntervention Type: Dietary Supplement Intervention Name: Diabetic Foot Ulcer Nutritional Protocol Description: A specific regimen of daily dietary supplements designed to support metabolic health and accelerated tissue repair in diabetic patients. The protocol involves the administration of targeted nutrients known to enhance collagen synthesis, reduce systemic inflammation.Participants consume the supplements orally on a daily basis over a 6-week period. The observation focuses on the supplement's ability to facilitate complete wound closure (epithelialization) and salvage limbs in patients previously scheduled for amputation. Study Status: Completed (s | Dietary supplement | Nutritional Supplements |
Primary outcome
Rate of Complete Wound Closure.
Time frame: 06 weeks
Measure Description: Percentage of participants achieving full epithelialization of the target ulcer, defined as the absence of drainage and no further requirement for clinical dressing.
Rate of Complete Wound Closure
Time frame: Baseline and 6 weeks.
Outcome Measure Title: Rate of Complete Wound Closure Measure Description: Percentage of participants achieving full epithelialization of the target ulcer, defined as the absence of drainage and no further requirement for clinical dressing. Time Frame: 6 weeks. Outcome Measure Title: Incidence of Lower Extremity Amputation Measure Description: Number of participants requiring minor (toe/transmetatarsal) or major (above/below-knee) amputations during the observation period. Time Frame: Up to 6 weeks. Outcome Measure Title: Time to Complete Wound Closure Measure Description: Number of weeks required to reach full clinical healing (100% epithelialization) for participants achieving closure. Time Frame: Weekly for up to 6 weeks. Outcome Measure Title: Change in Wound Surface Area Measure Description: Measurement of the variation in the ulcer's physical dimensions (length x width in millimeters) from baseline to the final assessment.
Incidence of Lower Extremity Amputation.
Time frame: Up to 06 weeks
Outcome Measure Title: Time to Complete Wound Closure Measure Description: Number of weeks required to reach full clinical healing (100% epithelialization) for participants achieving closure. Time Frame: Weekly for up to 6 weeks. Outcome Measure Title: Change in Wound Surface Area Measure Description: Measurement of the variation in the ulcer's physical dimensions (length x width in millimeters) from baseline to the final assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Salvage and Diabetes Complication, run by Amar h Zireg at 1 site in Algeria.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Wound Closure. (time frame: 06 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.