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This is a prospective randomized trial wherein participants will be assigned to NutraHealâ„¢, NutraHeal Plusâ„¢, 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.
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 NutraHealâ„¢ (n=15), NutraHeal Plusâ„¢ (n=15), or standard of care (n=15) for 1 week prior to surgery and 3 weeks after surgery. NutraHealâ„¢ 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 Plusâ„¢ 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 NutraHealâ„¢ or NutraHeal Plusâ„¢.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NutraHeal | Experimental | NutraHealâ„¢ 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 | Experimental | NutraHeal Plusâ„¢ 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). |
|
| Standard of Care | No Intervention | Receive standard of care for 1 week prior to surgery and 3 weeks after foot surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Pain Interference |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Physical Function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lenore Moyer, DPM | Advanced Regional Center for Ankle and Foot Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Regional Center for Ankle and Foot Care | Altoona | Pennsylvania | 16602 | United States | ||
| Advanced Regional Center for Ankle & Foot Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29369092 | Background | Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743. | |
| 30604414 |
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| ID | Term |
|---|---|
| D018409 | Foot Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
|
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. |
| 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. |
| 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 |
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. |
| 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. |
| Ebensburg |
| Pennsylvania |
| 15931 |
| United States |
| Advanced Regional Center for Ankle & Foot Care | State College | Pennsylvania | 16801 | United States |
| Background |
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