The study to evaluate effect of NutraHeal™ or NutraHeal Plus™ on recovery from foot surgery
The research company NutraHeal is conducting the clinical trial Nutritional Supplements and Foot Surgery.
This is a prospective randomized trial wherein participants will be assigned to NutraHeal™, NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery. The central hypothesis is that among patients undergoing surgery, nutritional supplements that maintain energy production, muscle structure, immune function, and response to pain will support recovery from surgery.
It is planned to include 45 participants.
Actual study start date is September 1, 2022. The researchers expect to complete the study by August 14, 2023.
One primary outcome measure is Wound Healing at 3 weeks after surgery, Wound healing (time, healing quality, erythema and new tissue quality), using a Likert rating scale against expected results from -4 (much worse) to +4 (much better) including the expected reference grade of zero (0). Positive scores are a better outcome.
Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05522179.
