Diabetic FootNCT03150901
Role of Adiponectine in Pathophysiology Ogf Diabetic Foot
An observational study of Diabetic Foot, run by Wolfson Medical Center.
Trial summary
Diabetic patients with a history of diabetic foot are considered to be a high-risk population for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is responsible for more hospitalizations than any other complication of diabetes and are the leading cause of non-traumatic lower extremity… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- no drug
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2015to 1 Feb 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetic patients hospitalized from January 2015 through December 2016 in Wolfson Medical Center due to the diagnosis of diabetic foot
Who may be able to join
- patients hospitalized from January 2015 through December 2016 in Wolfson Medical Center due to the diagnosis of diabetic foot
Who cannot join
- Patients with a history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study were excluded.
- Patients with unbalanced endocrine disease were excluded, as were patients with plasma creatinine > 2.5 mg/dl and elevation of liver enzymes to more than twice the upper normal limit.
About this study
Diabetic patients with a history of diabetic foot are considered to be a high-risk population for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is responsible for more hospitalizations than any other complication of diabetes and are the leading cause of non-traumatic lower extremity amputations, resulting in nearly 100 000 amputations annually in the US alone (4,5,6). Surgical debridement, as an important component of standard of care of diabetic foot, is intended to remove healing-impaired tissue, decreases bacterial burden, thus to stimulate overall wound closure, while removing as little of healing-competent skin as possible. Furthermore, debrided tissue is often used as a valuable tissue source for research purposes (7,8,9,10). Debrided tissue presents valuable diagnostic and research source to verify pathology, assess prognosis and gain insights into DF molecular pathology, all of which ultimately leads to improved outcomes.
We aimed to validate tissue obtained from surgical debridement of DF for the cellular/molecular tissue analyses and biomarkers, to evaluate the pathophysiology of DF and understanding mechanisms that inhibit healing.
Read more
The age range will be 50-70 years, in order to minimize the effects of irreversible vascular wall changes induced progressively by the aging process. All patients will undergo screening procedures that will include full anamnesis, physical examination, basic laboratory blood tests (full chemistry, CBC); urine examination and EKG will be performed at start and at the end of the study. Patients with a significant myocardial, and renal, cerebrovascular or hepatic disease will be excluded from the study.
In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF during surgical debridement. From each patient, 1-4 specimens will be obtained per debridement. To evaluate debrided tissue, each specimen will be processed for paraffin embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple specimens acquired from the same wound will be analysed.
Read the detailed description
Diabetic patients with a history of diabetic foot are considered to be a high-risk population for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is responsible for more hospitalizations than any other complication of diabetes and are the leading cause of non-traumatic lower extremity amputations, resulting in nearly 100 000 amputations annually in the US alone (4,5,6). Surgical debridement, as an important component of standard of care of diabetic foot, is intended to remove healing-impaired tissue, decreases bacterial burden, thus to stimulate overall wound closure, while removing as little of healing-competent skin as possible. Furthermore, debrided tissue is often used as a valuable tissue source for research purposes (7,8,9,10). Debrided tissue presents valuable diagnostic and research source to verify pathology, assess prognosis and gain insights into DF molecular pathology, all of which ultimately leads to improved outcomes.
We aimed to validate tissue obtained from surgical debridement of DF for the cellular/molecular tissue analyses and biomarkers, to evaluate the pathophysiology of DF and understanding mechanisms that inhibit healing.
The age range will be 50-70 years, in order to minimize the effects of irreversible vascular wall changes induced progressively by the aging process. All patients will undergo screening procedures that will include full anamnesis, physical examination, basic laboratory blood tests (full chemistry, CBC); urine examination and EKG will be performed at start and at the end of the study. Patients with a significant myocardial, and renal, cerebrovascular or hepatic disease will be excluded from the study.
In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF during surgical debridement. From each patient, 1-4 specimens will be obtained per debridement. To evaluate debrided tissue, each specimen will be processed for paraffin embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple specimens acquired from the same wound will be analysed. Full-thickness epidermis biopsies will be followed by biomarker assessment such as:
- Expression of insulin-like growth factor 1 receptor (IGF-1R)
- Adiponectin
- Leptin
- Resistin
- Osteocalcin
- Osteoprotegerin
- Insulin, c-peptid
- HOMA-IR Blood sampling for chemistry and metabolic markers including lipids, fasting glucose, fasting insulin, HbA1C, HOMA-IR , CRP, plasma adiponectin, visfatin, resistin, and plasma leptin will be performed. Additionally, relationship between serum and tissue adipokines level will be evaluated.
- Conditions
- Diabetic Foot
- Being tested
- no drug
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drugDiagnostic test
laboratory tests
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients | In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF during surgical debridement. From each patient, 1-4 specimens will be obtained per debridement. To evaluate debrided tissue, each specimen will be processed for paraffin embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple specimens acquired from the same wound will be analysed. Full-thickness epidermis biopsies will be followed by biomarker assessment such as:
1. Expression of insulin-like growth factor 1 receptor (IGF-1R)
2. Adiponectin
3. Leptin
4. Resistin
5. Osteocalcin
6. Osteoprotegerin
7. Insulin, c-peptid
8. HOMA-IR Receives: Diagnostic Test: no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
dIABETIC FOOT ULCERS INCIDENCE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start20 Feb 2015
- Primary completion1 Feb 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marina Shargorodsky, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150901
- Sponsor's protocol ID
- 0016-15-WOMC
- Status last verified
- Mar 2017
- First submitted
- 10 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adiponectine in Pathophysiology Ogf Diabetic Foot
- ClinicalTrials.gov ID
- NCT03150901
- Acronym / sponsor ID
- 0016-15-WOMC
- Conditions
- Diabetic Foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 12 May 2017 (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 patients with a history of diabetic foot are considered to be a high-risk population for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is responsible for more hospitalizations than any other complication of diabetes and are the leading cause of non-traumatic lower extremity amputations, resulting in nearly 100 000 amputations annually in the US alone (4,5,6). Surgical debridement, as an important component of standard of care of diabetic foot, is intended to remove healing-impaired tissue, decreases bacterial burden, thus to stimulate overall wound closure, while removing as little of healing-competent skin as possible. Furthermore, debrided tissue is often used as a valuable tissue source for research purposes (7,8,9,10). Debrided tissue presents valuable diagnostic and research source to verify pathology, assess prognosis and gain insights into DF molecular pathology, all of which ultimately leads to improved outcomes.
We aimed to validate tissue obtained from surgical debridement of DF for the cellular/molecular tissue analyses and biomarkers, to evaluate the pathophysiology of DF and understanding mechanisms that inhibit healing.
The age range will be 50-70 years, in order to minimize the effects of irreversible vascular wall changes induced progressively by the aging process. All patients will undergo screening procedures that will include full anamnesis, physical examination, basic laboratory blood tests (full chemistry, CBC); urine examination and EKG will be performed at start and at the end of the study. Patients with a significant myocardial, and renal, cerebrovascular or hepatic disease will be excluded from the study.
In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF during surgical debridement. From each patient, 1-4 specimens will be obtained per debridement. To evaluate debrided tissue, each specimen will be processed for paraffin embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple specimens acquired from the same wound will be analysed.
Detailed description
Diabetic patients with a history of diabetic foot are considered to be a high-risk population for increased cardiovascular and all-cause mortality (1,2,3,). Diabetic foot (DF) is responsible for more hospitalizations than any other complication of diabetes and are the leading cause of non-traumatic lower extremity amputations, resulting in nearly 100 000 amputations annually in the US alone (4,5,6). Surgical debridement, as an important component of standard of care of diabetic foot, is intended to remove healing-impaired tissue, decreases bacterial burden, thus to stimulate overall wound closure, while removing as little of healing-competent skin as possible. Furthermore, debrided tissue is often used as a valuable tissue source for research purposes (7,8,9,10). Debrided tissue presents valuable diagnostic and research source to verify pathology, assess prognosis and gain insights into DF molecular pathology, all of which ultimately leads to improved outcomes.
We aimed to validate tissue obtained from surgical debridement of DF for the cellular/molecular tissue analyses and biomarkers, to evaluate the pathophysiology of DF and understanding mechanisms that inhibit healing.
The age range will be 50-70 years, in order to minimize the effects of irreversible vascular wall changes induced progressively by the aging process. All patients will undergo screening procedures that will include full anamnesis, physical examination, basic laboratory blood tests (full chemistry, CBC); urine examination and EKG will be performed at start and at the end of the study. Patients with a significant myocardial, and renal, cerebrovascular or hepatic disease will be excluded from the study.
In a prospective study, we will collect wound edge tissue specimens from 75 patients with DF during surgical debridement. From each patient, 1-4 specimens will be obtained per debridement. To evaluate debrided tissue, each specimen will be processed for paraffin embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple specimens acquired from the same wound will be analysed. Full-thickness epidermis biopsies will be followed by biomarker assessment such as:
- Expression of insulin-like growth factor 1 receptor (IGF-1R)
- Adiponectin
- Leptin
- Resistin
- Osteocalcin
- Osteoprotegerin
- Insulin, c-peptid
- HOMA-IR Blood sampling for chemistry and metabolic markers including lipids, fasting glucose, fasting insulin, HbA1C, HOMA-IR , CRP, plasma adiponectin, visfatin, resistin, and plasma leptin will be performed. Additionally, relationship between serum and tissue adipokines level will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic patients | – | Diagnostic Test: no drugIn a prospective study, we will collect wound edge tissue specimens from 75 patients with DF during surgical debridement. From each patient, 1-4 specimens will be obtained per debridement. To evaluate debrided tissue, each specimen will be processed for paraffin embedding and stained with haematoxylin and eosin. Histopathology analysis of multiple specimens acquired from the same wound will be analysed. Full-thickness epidermis biopsies will be followed by biomarker assessment such as: 1. Expression of insulin-like growth factor 1 receptor (IGF-1R) 2. Adiponectin 3. Leptin 4. Resistin 5. Osteocalcin 6. Osteoprotegerin 7. Insulin, c-peptid 8. HOMA-IR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients hospitalized from January 2015 through December 2016 in Wolfson Medical Center due to the diagnosis of diabetic foot
Key inclusion criteria (1 listed)
- patients hospitalized from January 2015 through December 2016 in Wolfson Medical Center due to the diagnosis of diabetic foot
Key exclusion criteria (2 listed)
- Patients with a history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study were excluded.
- Patients with unbalanced endocrine disease were excluded, as were patients with plasma creatinine > 2.5 mg/dl and elevation of liver enzymes to more than twice the upper normal limit.
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 |
|---|---|---|
| no druglaboratory tests | Diagnostic test | diabetic patients |
Primary outcome
dIABETIC FOOT ULCERS INCIDENCE
Time frame: 1 year
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 12 May 2017.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Wolfson Medical Center.
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 2 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 12 May 2017. 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?
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?
dIABETIC FOOT ULCERS INCIDENCE (time frame: 1 year). 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 12 May 2017.