Role of Adiponectine in Pathophysiology Ogf Diabetic Foot
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Observational

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 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:

        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 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.
    

Intervention name(s): no drug
Intervention type(s): Diagnostic Test
Intervention description(s): laboratory tests
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        diabetic patients hospitalized from January 2015 through December 2016 in Wolfson Medical
        Center due to the diagnosis of diabetic foot