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Completed

NCT Number: NCT05522179

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Regional Center for Ankle and Foot Care, Altoona, Pennsylvania, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NutraHeal

Dietary Supplement

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.

NutraHeal Plus

Dietary Supplement

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.

Primary outcomes

  1. Wound Healing at 3 weeks after surgery

    Time frame: 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 outcomes

  1. Pain Intensity

    Time frame: 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.

  2. Pain Interference

    Time frame: 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.

  3. Fatigue

    Time frame: 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.

  4. Wound Healing at 1 week after surgery

    Time frame: 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 outcomes

  1. Sleep Disturbance

    Time frame: 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.

  2. Physical Function

    Time frame: 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.

  3. Patient Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NutraHeal

Industry

Registry information

Official study title

Nutritional Supplements to Support Recovery After Foot Surgery - A Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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