Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Marcus L. Gitterle, MD, FACCWS
CONTACT
Tarek Ibrahim, MBA
CONTACT
Lead
Estar Medical dba Medical Technologies, LTD
With
Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, where they will receive standard of care Including- * nutritional supplementation for 2 weeks, * wound assessment with photos and measurements, * wound care including cleansing and debridement, * wound dressings, * mild compression of the lower extremity, and * off-loading with a removable boot. Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic. In addition to standard of care, Tropocells Autologous PRF Systems gel clot will be placed on the wound bed after cleansing and debridement prior to wound dressing and off-loading. Data will be captured for: Primary Outcome- Clinical Performance with complete wound closure, and Secondary Outcome(s)- * Safety assessing adverse events (AE) and severe adverse events (SAE), * Measures of Clinical Performance including, * trajectory of wound area reduction * percent (%) of area reduction, * proportion of wound area reduction Follow-up Phase (1 month and 3 months): participants that have 100% wound closure with two weekly assessments demonstrating persistent closure, will be advanced to the follow-up phase, where they will be assessed at 1 month and 3 months with photos and measurements to show if they remain closed.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
