Foot Injuries and Disorders
Conditions
Keywords
Nutritional supplements
Brief summary
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.
Detailed description
Over a 6 month period the investigators will enroll 45 male and female patients undergoing foot surgery. This is a prospective randomized trial and participants will be assigned to NutraHeal™ (n=15), NutraHeal Plus™ (n=15), or standard of care (n=15) for 1 week prior to surgery and 3 weeks after surgery. NutraHeal™ is a nutritional supplement that contains 7.5 micrograms (300 IU) of Vitamin D3, 80 mg of Calcium as Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, and 45 mg of Bromelain. NutraHeal Plus™ is a nutritional supplement that contains 80 mg of Calcium as Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, 45 mg of Bromelain, and 7.5 mg of reduced Nicotinamide Adenine Dinucleotide (NADH). Patients randomized to standard of care will not receive any of the ingredients in NutraHeal™ or NutraHeal Plus™. The foot surgeon will evaluate the patient for 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). Wound healing will be assessed at 1 and 3 weeks after surgery. Patients will document medication compliance (day of surgery, 1 and 3 weeks after surgery), pain medication use (baseline, on the day of surgery and at 1 and 3 weeks after surgery) and rate overall satisfaction (5-point scale (1 = excellent; 2 = good; 3 = moderate; 4 = sufficient; 5 = unsatisfactory) at 3 weeks after surgery). Patients will also complete the PROMIS-29 instrument at baseline, the day of surgery, and at 1 and 3 weeks after surgery).
Interventions
DIETARY_SUPPLEMENTNutraHeal
Receive NutraHeal (2 capsules twice a day) as a dietary supplement beginning 1 week prior to surgery and extending to 3 weeks after foot surgery.
DIETARY_SUPPLEMENTNutraHeal Plus
Receive NutraHeal Plus (2 capsules twice a day) as a dietary supplement beginning 1 week prior to surgery and extending to 3 weeks after foot surgery.
Sponsors
NutraHeal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing at 3 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | 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. |
| Pain Intensity | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | 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. |
| Fatigue | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | 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. |
| Wound Healing at 1 week after surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 3 weeks after surgery. | 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. |
| Physical Function | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | 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. |
| Sleep Disturbance | Baseline, the day of surgery, and at 1 and 3 weeks after surgery. | 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. |
Countries
United States
Outcome results
None listed