Diabetic FootNCT06552910
Analyzing Anesthetic Techniques in Diabetic Foot Amputation
An observational study of Diabetic Foot and Amputation, Surgical, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes Introduction: Diabetic foot is a severe complication of diabetes, often resulting in ulceration, osteomyelitis, and gangrene. Amputation or surgical debridement is the standard treatment for advanced cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Amputation, Surgical
- What is being tested?
- Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Population Description The study population consisted of patients diagnosed with diabetic foot who required amputation and were treated at Ankara Bilkent City Hospital between 2021 and 2023. The population included adults aged 18 years and older, irrespective of sex. This cohort was selected through a retrospective chart review method, ensuring comprehensive inclusion of all eligible patients who underwent toe, ankle, or foot amputations due to diabetic foot during the specified period. The primary focus was on evaluating the outcomes associated with different anesthetic techniques used during these procedures. Sampling Method: Non-Probability Sample Minimum Age: 18 Years Maximum Age: Not applicable Sex: All Gender-Based: No Accepts Healthy Volunteers: No
Who may be able to join
- Patients diagnosed with diabetic foot requiring amputation. Patients who underwent toe, ankle, or foot amputation. Patients aged 18 years or older.
Who cannot join
- Patients under the age of 18. Amputations performed for reasons other than diabetic foot. Patients with incomplete or insufficient medical records.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Semih Başkan
Etimesgut, Ankara, 06790
Semih Başkan, 05326030675, drsemkan@gmail.com
About this study
Official title: Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes
Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes
Introduction:
Read more
Diabetic foot is a severe complication of diabetes, often resulting in ulceration, osteomyelitis, and gangrene. Amputation or surgical debridement is the standard treatment for advanced cases. The study aims to evaluate the outcomes of different anesthetic techniques in diabetic foot amputation, specifically comparing peripheral nerve block (PNB) and general anesthesia.
Objective:
To assess the impact of anesthetic procedures on outcomes in diabetic foot amputation cases using inpatient data. The hypothesis is that PNB will result in fewer postoperative complications than general anesthesia-primary outcome: 30-day mortality; secondary outcomes: composite morbidity and hospital discharge duration.
Materials and Methods:
This retrospective chart review will analyze medical records of patients with diabetic foot at Ankara Bilkent City Hospital from 2021 to 2023. Inclusion criteria: patients who underwent toe, ankle, or foot amputations. Exclusion criteria: patients under 18, amputations for non-diabetic reasons, and insufficient medical data. Data will include patient demographics, preoperative medications, comorbidities, and surgical details. Major complications, secondary outcomes, and mortality will be primary measures.
Statistical Analysis:
Descriptive statistics will summarize patient characteristics. Chi-square and Student t-tests will analyze associations between anesthesia type and postoperative outcomes. Kaplan-Meier survival analysis will compare hospital stay durations. Logistic regression will adjust for confounders and assess the impact of anesthetics on complications. Results will be significant at p < 0.05.
Read the detailed description
Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes Introduction Diabetic foot is a clinical manifestation of diabetes with a wide range of symptoms, including ulceration, osteomyelitis, osteoarticular destruction, and gangrene, as a consequence of advanced disease. Some cases of diabetic foot present general indications for amputation, including dead limbs, threat to the patient's life, pain, loss of function, or nuisance. Surgical debridement or amputation is the standard treatment for this condition. Multiple debridement operations, however, have been shown in recent research to considerably improve wound healing rates, making them a potential therapeutic alternative. The majority of patients with diabetic foot ulcers are older, have had diabetes for a longer period, have numerous organ problems, and at least one comorbid ailment.
As neuraxial anesthesia, a type of regional anesthetic, does not require positive mechanical breathing and offers superior pain management, less surgical stress response, and enhanced blood flow, it should theoretically result in a better prognosis than general anesthesia. However, due to the increased incidence of macrovascular complications such as peripheral artery occlusive disease, cerebrovascular disease, and coronary heart disease in patients undergoing diabetic foot amputation, prophylactic or therapeutic anticoagulation is necessary. On the other hand, peripheral nerve block (PNB) shares many theoretical advantages of regional anesthesia and can be beneficial in these cases.
The goal of the research is to assess the outcomes of anesthetic procedures carried out in diabetic foot amputation cases using data from an inpatient database. The hypothesis is that peripheral nerve block will be less likely than general anesthesia to cause postoperative complications. The primary outcome is 30-day mortality following lower extremity amputation; secondary outcomes include composite morbidity from potentially fatal sequelae and hospital discharge duration.
Materials and Methods This study will be conducted using a retrospective chart review method. The study will utilize data from the medical records of patients. Medical data from patients with diabetic foot at Ankara Bilkent City Hospital between 2021 and 2023 will be included in the study. These patients will include those who have toe, ankle, or foot amputations. This research will encompass all individuals who had surgery during this time. Patients with diabetic feet who had their feet, ankles, or toes amputated will meet the inclusion criteria. Exclusion criteria will include those under the age of 18, those whose amputations were performed for reasons other than diabetic foot, and those with insufficient medical data.
Since this study will be conducted retrospectively, the choice of anesthesia method was based on clinical experience.
Using the hospital information management system, patients' medical records will be examined retrospectively. Baseline patient demographic data will include age, sex, height, weight, body mass index, nature of the procedure, smoking status, and American Society of Anesthesiologists physical status classification. Preoperative medication records will be gathered, including beta-blockers, calcium channel blockers, insulin, renin-angiotensin system antagonists, anticoagulant or antiplatelet medicines, and HMG-CoA reductase inhibitors. The patients' comorbidities will also be collected, including the presence of a wound infection, bleeding disorders, sepsis, and whether the surgery was an emergency. Additionally, the history of diabetes, the number of pack-years of smoking, and histories of chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, chronic kidney disease, and steroid dependence will be documented. Preoperative values of hematocrit, hemoglobin, platelets, creatinine, and albumin will be collected, along with details of the type of anesthesia (general, spinal, or epidural), length of surgery, intraoperative blood loss, postoperative pain ratings, and complications.
Major complications will include pneumonia (as defined by the European Perioperative Clinical Outcome guidelines), myocardial infarction (as defined by the World Health Organization), stroke (defined as a central neurologic deficit persisting postoperatively for more than 24 hours), venous thromboembolism (confirmed on imaging), delirium (confirmed by a psychiatrist), acute kidney injury (as defined by the Kidney Disease: Improving Global Outcomes Criteria), new requirement for dialysis, surgical site infection, and re-operation. Secondary outcomes and mortality will be the primary outcome measures.
Statistical Analysis Descriptive statistics will be employed to summarize the demographic and clinical characteristics of the patients. The association between the type of anesthesia used and postoperative outcomes will be analyzed using the Chi-square test for categorical variables and the Student's t-test for continuous variables. Kaplan-Meier survival analysis will be conducted to estimate survival rates and compare durations of hospital stays between patients receiving different types of anesthesia. Logistic regression will be used to adjust for potential confounders and assess the impact of anesthetic techniques on postoperative complications. Results will be considered statistically significant at a p-value of less than 0.05. All statistical analyses will be performed using the hospital information management system.
- Conditions
- Diabetic Foot, Amputation, Surgical
- Being tested
- Nerve Block
- Keywords
- Diabetic Foot, Nerve Block, Diabetes Complications, Amputation, Surgical
- Medical subject headings
- Diabetic Foot, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve BlockProcedure or surgery
Since this study was conducted retrospectively, the choice of anesthesia method was made based on our own experience. For every patient undergoing LEA under PNB, a popliteal sciatic nerve block was carried out. A saphenous nerve block was also carried out if the procedure was on a level that was close to the metatarsal bone. In some circumstances (distal surgery, such as the metatarsal bone), a sensory block on the surgical site was tried following the popliteal sciatic nerve block to demonstrate that the saphenous nerve's anatomic abnormalities required an additional saphenous nerve block. The related block was later carried out, if needed. Under ultrasound guidance, every PNB was finished.
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort 1 | Label: Peripheral Nerve Block Description: Injection of anesthetic near specific nerves to block sensation in a particular area of the body. Receives: Procedure: Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Mortality Rate in Patients Undergoing Diabetic Foot Amputation
This study aims to evaluate the 30-day mortality rate in patients undergoing diabetic foot amputation. Mortality rate is defined as the occurrence of death within 30 days following surgery. The primary focus is to compare the short-term survival effects of different anesthesia techniques (general anesthesia and peripheral nerve block) on these patients.
Measured: Time Frame: 30 days post-surgery.
Secondary outcomes (2)
Composite Morbidity from Potentially Fatal Sequelae
This secondary outcome measure evaluates the occurrence of composite morbidity resulting from potentially fatal sequelae in patients undergoing diabetic foot amputation. This includes major complications such as pneumonia, myocardial infarction, stroke, venous thromboembolism, delirium, acute kidney injury, new requirement for dialysis, surgical site infection, and re-operation. The aim is to assess how different anesthesia techniques impact the rate and severity of these complications.
Measured: From the date of surgery until hospital discharge, assessed up to 3 months.
Hospital Discharge Duration
This secondary outcome measure focuses on the length of hospital stay following diabetic foot amputation. It aims to determine whether the type of anesthesia used (general anesthesia or peripheral nerve block) influences the duration of hospitalization, thereby providing insights into recovery times and healthcare resource utilization.
Measured: From the date of surgery until hospital discharge, assessed up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (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 Diabetic FootStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, semih başkan, Ankara City Hospital Bilkent
- Investigators
- Semih Başkan, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552910
- Sponsor's protocol ID
- SMH1
- Status last verified
- Sep 2024
- First submitted
- 22 Jul 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Primadhi RA, Septrina R, Hapsari P, Kusumawati M. Amputation in diabetic foot ulcer: A treatment dilemma. World J Orthop. 2023 May 18;14(5):312-318. doi: 10.5312/wjo.v14.i5.312. eCollection 2023 May 18.
PubMed 37304194Zhu G, Xu J, Dai H, Min D, Guo G. Effect of peripheral nerve block versus general anesthesia on the hemodynamics and prognosis of diabetic patients undergoing diabetic foot Surgery. Diabetol Metab Syndr. 2023 Oct 26;15(1):213. doi: 10.1186/s13098-023-01185-9.
PubMed 37880794Kim HJ, Park CG, Choi YS, Lee YS, Kwak HJ. Effects of Anesthetic Techniques on the Risk of Postoperative Complications Following Lower Extremity Amputation in Diabetes Patients with Coagulation Abnormalities: A Retrospective Cohort Study Using Propensity Score Analysis. J Clin Med. 2021 Nov 28;10(23):5598. doi: 10.3390/jcm10235598.
PubMed 34884298
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes
- ClinicalTrials.gov ID
- NCT06552910
- Acronym / sponsor ID
- SMH1
- Conditions
- Diabetic Foot, Amputation, Surgical
- Keywords
- Diabetic Foot, Nerve Block, Diabetes Complications, Amputation, Surgical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 Aug 2024 (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.
Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes
Introduction:
Diabetic foot is a severe complication of diabetes, often resulting in ulceration, osteomyelitis, and gangrene. Amputation or surgical debridement is the standard treatment for advanced cases. The study aims to evaluate the outcomes of different anesthetic techniques in diabetic foot amputation, specifically comparing peripheral nerve block (PNB) and general anesthesia.
Objective:
To assess the impact of anesthetic procedures on outcomes in diabetic foot amputation cases using inpatient data. The hypothesis is that PNB will result in fewer postoperative complications than general anesthesia-primary outcome: 30-day mortality; secondary outcomes: composite morbidity and hospital discharge duration.
Materials and Methods:
This retrospective chart review will analyze medical records of patients with diabetic foot at Ankara Bilkent City Hospital from 2021 to 2023. Inclusion criteria: patients who underwent toe, ankle, or foot amputations. Exclusion criteria: patients under 18, amputations for non-diabetic reasons, and insufficient medical data. Data will include patient demographics, preoperative medications, comorbidities, and surgical details. Major complications, secondary outcomes, and mortality will be primary measures.
Statistical Analysis:
Descriptive statistics will summarize patient characteristics. Chi-square and Student t-tests will analyze associations between anesthesia type and postoperative outcomes. Kaplan-Meier survival analysis will compare hospital stay durations. Logistic regression will adjust for confounders and assess the impact of anesthetics on complications. Results will be significant at p < 0.05.
Detailed description
Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes Introduction Diabetic foot is a clinical manifestation of diabetes with a wide range of symptoms, including ulceration, osteomyelitis, osteoarticular destruction, and gangrene, as a consequence of advanced disease. Some cases of diabetic foot present general indications for amputation, including dead limbs, threat to the patient's life, pain, loss of function, or nuisance. Surgical debridement or amputation is the standard treatment for this condition. Multiple debridement operations, however, have been shown in recent research to considerably improve wound healing rates, making them a potential therapeutic alternative. The majority of patients with diabetic foot ulcers are older, have had diabetes for a longer period, have numerous organ problems, and at least one comorbid ailment.
As neuraxial anesthesia, a type of regional anesthetic, does not require positive mechanical breathing and offers superior pain management, less surgical stress response, and enhanced blood flow, it should theoretically result in a better prognosis than general anesthesia. However, due to the increased incidence of macrovascular complications such as peripheral artery occlusive disease, cerebrovascular disease, and coronary heart disease in patients undergoing diabetic foot amputation, prophylactic or therapeutic anticoagulation is necessary. On the other hand, peripheral nerve block (PNB) shares many theoretical advantages of regional anesthesia and can be beneficial in these cases.
The goal of the research is to assess the outcomes of anesthetic procedures carried out in diabetic foot amputation cases using data from an inpatient database. The hypothesis is that peripheral nerve block will be less likely than general anesthesia to cause postoperative complications. The primary outcome is 30-day mortality following lower extremity amputation; secondary outcomes include composite morbidity from potentially fatal sequelae and hospital discharge duration.
Materials and Methods This study will be conducted using a retrospective chart review method. The study will utilize data from the medical records of patients. Medical data from patients with diabetic foot at Ankara Bilkent City Hospital between 2021 and 2023 will be included in the study. These patients will include those who have toe, ankle, or foot amputations. This research will encompass all individuals who had surgery during this time. Patients with diabetic feet who had their feet, ankles, or toes amputated will meet the inclusion criteria. Exclusion criteria will include those under the age of 18, those whose amputations were performed for reasons other than diabetic foot, and those with insufficient medical data.
Since this study will be conducted retrospectively, the choice of anesthesia method was based on clinical experience.
Using the hospital information management system, patients' medical records will be examined retrospectively. Baseline patient demographic data will include age, sex, height, weight, body mass index, nature of the procedure, smoking status, and American Society of Anesthesiologists physical status classification. Preoperative medication records will be gathered, including beta-blockers, calcium channel blockers, insulin, renin-angiotensin system antagonists, anticoagulant or antiplatelet medicines, and HMG-CoA reductase inhibitors. The patients' comorbidities will also be collected, including the presence of a wound infection, bleeding disorders, sepsis, and whether the surgery was an emergency. Additionally, the history of diabetes, the number of pack-years of smoking, and histories of chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, chronic kidney disease, and steroid dependence will be documented. Preoperative values of hematocrit, hemoglobin, platelets, creatinine, and albumin will be collected, along with details of the type of anesthesia (general, spinal, or epidural), length of surgery, intraoperative blood loss, postoperative pain ratings, and complications.
Major complications will include pneumonia (as defined by the European Perioperative Clinical Outcome guidelines), myocardial infarction (as defined by the World Health Organization), stroke (defined as a central neurologic deficit persisting postoperatively for more than 24 hours), venous thromboembolism (confirmed on imaging), delirium (confirmed by a psychiatrist), acute kidney injury (as defined by the Kidney Disease: Improving Global Outcomes Criteria), new requirement for dialysis, surgical site infection, and re-operation. Secondary outcomes and mortality will be the primary outcome measures.
Statistical Analysis Descriptive statistics will be employed to summarize the demographic and clinical characteristics of the patients. The association between the type of anesthesia used and postoperative outcomes will be analyzed using the Chi-square test for categorical variables and the Student's t-test for continuous variables. Kaplan-Meier survival analysis will be conducted to estimate survival rates and compare durations of hospital stays between patients receiving different types of anesthesia. Logistic regression will be used to adjust for potential confounders and assess the impact of anesthetic techniques on postoperative complications. Results will be considered statistically significant at a p-value of less than 0.05. All statistical analyses will be performed using the hospital information management system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort 1 | – | Procedure: Nerve BlockLabel: Peripheral Nerve Block Description: Injection of anesthetic near specific nerves to block sensation in a particular area of the body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population Description The study population consisted of patients diagnosed with diabetic foot who required amputation and were treated at Ankara Bilkent City Hospital between 2021 and 2023. The population included adults aged 18 years and older, irrespective of sex. This cohort was selected through a retrospective chart review method, ensuring comprehensive inclusion of all eligible patients who underwent toe, ankle, or foot amputations due to diabetic foot during the specified period. The primary focus was on evaluating the outcomes associated with different anesthetic techniques used during these procedures. Sampling Method: Non-Probability Sample Minimum Age: 18 Years Maximum Age: Not applicable Sex: All Gender-Based: No Accepts Healthy Volunteers: No
Key inclusion criteria (1 listed)
- Patients diagnosed with diabetic foot requiring amputation. Patients who underwent toe, ankle, or foot amputation. Patients aged 18 years or older.
Key exclusion criteria (1 listed)
- Patients under the age of 18. Amputations performed for reasons other than diabetic foot. Patients with incomplete or insufficient medical records.
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 |
|---|---|---|
| Nerve BlockSince this study was conducted retrospectively, the choice of anesthesia method was made based on our own experience. For every patient undergoing LEA under PNB, a popliteal sciatic nerve block was carried out. A saphenous nerve block was also carried out if the procedure was on a level that was close to the metatarsal bone. In some circumstances (distal surgery, such as the metatarsal bone), a sensory block on the surgical site was tried following the popliteal sciatic nerve block to demonstrate that the saphenous nerve's anatomic abnormalities required an additional saphenous nerve block. The related block was later carried out, if needed. Under ultrasound guidance, every PNB was finished. | Procedure or surgery | Group/Cohort 1 |
Primary outcome
30-Day Mortality Rate in Patients Undergoing Diabetic Foot Amputation
Time frame: Time Frame: 30 days post-surgery.
This study aims to evaluate the 30-day mortality rate in patients undergoing diabetic foot amputation. Mortality rate is defined as the occurrence of death within 30 days following surgery. The primary focus is to compare the short-term survival effects of different anesthesia techniques (general anesthesia and peripheral nerve block) on these patients.
2 secondary outcomes
Composite Morbidity from Potentially Fatal Sequelae
Time frame: From the date of surgery until hospital discharge, assessed up to 3 months.
Hospital Discharge Duration
Time frame: From the date of surgery until hospital discharge, assessed up to 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Results publication: PubMed 37304194Primadhi RA, Septrina R, Hapsari P, Kusumawati M. Amputation in diabetic foot ulcer: A treatment dilemma. World J Orthop. 2023 May 18;14(5):312-318. doi: 10.5312/wjo.v14.i5.312. eCollection 2023 May 18.
- Results publication: PubMed 37880794Zhu G, Xu J, Dai H, Min D, Guo G. Effect of peripheral nerve block versus general anesthesia on the hemodynamics and prognosis of diabetic patients undergoing diabetic foot Surgery. Diabetol Metab Syndr. 2023 Oct 26;15(1):213. doi: 10.1186/s13098-023-01185-9.
- Results publication: PubMed 34884298Kim HJ, Park CG, Choi YS, Lee YS, Kwak HJ. Effects of Anesthetic Techniques on the Risk of Postoperative Complications Following Lower Extremity Amputation in Diabetes Patients with Coagulation Abnormalities: A Retrospective Cohort Study Using Propensity Score Analysis. J Clin Med. 2021 Nov 28;10(23):5598. doi: 10.3390/jcm10235598.
- Individual participant dataSharing planned: No
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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.
Semih Başkan study director
Ankara City Hospital Bilkent
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 Diabetic Foot and Amputation, Surgical, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semih Başkan, MD (+905326030675, drsemkan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Mortality Rate in Patients Undergoing Diabetic Foot Amputation (time frame: Time Frame: 30 days post-surgery.). 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 NCT06552910, 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 5 Sep 2024.