Foot Injuries and Disorders Clinical Trial
Official title:
Nutritional Supplements to Support Recovery After Foot Surgery - A Pilot Study
NCT number | NCT05522179 |
Other study ID # | NH001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 29, 2022 |
Est. completion date | July 30, 2023 |
Verified date | July 2023 |
Source | NutraHeal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | July 30, 2023 |
Est. primary completion date | March 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - = 20 years of age - Undergoing foot surgery (matrixectomy (ingrown toenail removal) and wart removal) Exclusion Criteria: - > 80 years of age - Pregnant patients or those anticipating pregnancy in the 1 month study period - Allergic to pineapple - Treated with oral anticoagulation - Currently receiving Bromelain, Hydroxymethylbutyrate Monohydrate (HMB), reduced Nicotinamide Adenine Dinucleotide (NADH), Vitamin D3, or Zinc. - Alcoholism (>2 drinks/day) - Insulin Dependent Diabetes - Hepatic insufficiency (prior known liver function tests > 1.5 times the upper limit of normal) - Renal failure (prior known creatinine > 2.0 mg/dl) - Severe pulmonary disease (requiring home oxygen therapy) - Psychiatric illness requiring therapy (DSM-V thought disorders, recurrent major depressive disorder) |
Country | Name | City | State |
---|---|---|---|
United States | Advanced Regional Center for Ankle and Foot Care | Altoona | Pennsylvania |
United States | Advanced Regional Center for Ankle & Foot Care | Ebensburg | Pennsylvania |
United States | Advanced Regional Center for Ankle & Foot Care | State College | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
NutraHeal |
United States,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sleep Disturbance | Sleep disturbance over previous 7 days as recorded in PROMIS-29. Sleep quality is assessed on a scale of 1-5 (1 = very good, 2 = good, 3= fair, 4 = poor, 5 = very poor). Higher scores indicate a worse outcome. | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | |
Other | Physical Function | Physical function as recorded in PROMIS-29. Physical function is assessed on a scale of 1-5 (1 = without any difficulty, 2 = with a little difficulty, 3= with some difficulty, 4 = with much difficulty, 5 = unable to do). Higher scores indicate a worse outcome. | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | |
Other | Patient Satisfaction | Overall satisfaction with 1) use of the nutritional supplements and 2) wound healing. Satisfaction is assessed on a scale of 1-5 (1 = excellent, 2 = good, 3 = moderate, 4 = sufficient, 5 = unsatisfactory). Higher scores indicate a worse outcome. | 3 weeks after surgery. | |
Primary | 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. | 3 weeks after surgery. | |
Secondary | Pain Intensity | Average pain intensity over previous 7 days as recorded in PROMIS-29. Pain intensity is graded on a visual analog scale from 0 (no pain) to 10 (worst imaginable pain). Higher scores mean a worse outcome. | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | |
Secondary | Pain Interference | Average pain interference over previous 7 days as recorded in PROMIS-29. Pain interference is graded on a scale of 1-5 (1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much). Higher scores mean a worse outcome. | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | |
Secondary | Fatigue | Fatigue over previous 7 days as recorded in PROMIS-29. Fatigue is graded on a scale of 1-5 (1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much). Higher scores mean a worse outcome. | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | |
Secondary | Wound Healing at 1 week 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. | 1 week after surgery |
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