Diabetes Mellitus Clinical Trial
Official title:
Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation,
proliferation, maturation and remodelling.
In the young, damage to an organ mostly triggers fully regenerative mechanisms called
"primary" wound healing. Repeated damage in young individuals may cause "secondary" wound
healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.
Organ failure in the ageing organism is characterized by a progressive loss of its
capability to achieve an orderly reactivation of organ repair, and results in a combination
of chronic inflammation and fibroproliferative, non-regenerative repair affecting several
organs, including lung, liver and skin.
RESOLVE's objective is to identify, characterize, and validate molecular targets responsible
for shifting primary organ repair towards fibroproliferative wound healing as a result of an
age-dependent loss of regulatory control.
The structured approach is based on
- different forms of wound healing,
- different human diseases and
- different genetic backgrounds,
aiming to provide future diagnostic tools in various organs, to create transgenic animal
test systems, and to identify molecular targets involved in fibroproliferative wound
healing.
Cutaneous scars are frequently encountered conditions. The process of wound repair, however,
is complicated, and various factors contribute to different types of scarring (eg.
hypertrophic, atrophic).
WP 2.1: Regular skin repair
In elective plastic surgery most excised operative skin specimens are usually discarded, and
represent an excellent opportunity of harvesting skin biopsies without additional invasive
measures. This work package analyzes skin samples of individuals after elective plastic
surgery with normal wound healing serving as control group.
WP 2.2: Skin repair with and without hypertrophic scar formation
A classic example of fibroproliferative repair in the skin is hypertrophic scarring
classified as a dermal skin lesion, which is raised above skin level, stays within the
confines of the initial wound and increases in size by pushing out the margins of the scar
without invading the surrounding normal tissue.
Hypertrophic scarring is a condition commonly observed after burns and in regions of
prolonged wound healing (>21 days). The underlying pathology of hypertrophic scarring,
however, is poorly understood. Hypertrophic scars can be managed conservatively, and only
require surgical intervention under special circumstances.
This work package analyzes the clinical and molecular response to a standard treatment
regimen in skin regions with and without hypertrophic scars after skin injuries.
WP 2.4: Wound healing in normal and diabetic individuals
Diabetes mellitus is a known factor to cause impaired wound healing. Due to
microangiopathic, macroangiopathic and other conditions resulting from atherosclerosis and
peripheral neuropathy wound healing in diabetic individuals is usually delayed (hypotrophic,
atrophic) and often complicated by immunosuppression and superinfections. The rising
prevalence of diabetes mellitus in the elderly population makes it necessary to understand
its related processes in relevant clinical wound models.
Split-thickness skin-grafting is a commonly applied technique in plastic surgery, and donor
sites of previously uninjured skin regions spontaneously heal within two weeks, representing
an ideal condition to monitor clinical and molecular changes in diseased vs. non-diseased
states.
This work package analyzes skin repair in donor sites of split-thickness skin grafts in
non-diabetic and diabetic individuals.
;
Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |