Nutritional Supplements to Support Recovery After Foot Surgery - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Wound Healing at 3 weeks after surgery
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20 years of age
- •Undergoing foot surgery (matrixectomy (ingrown toenail removal) and wart removal)
排除标准
- •> 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)
结局指标
主要结局
Wound Healing at 3 weeks after surgery
时间窗: 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.
次要结局
- Pain Intensity(Baseline, the day of surgery, and at 1 and 3 weeks after surgery.)
- Pain Interference(Baseline, the day of surgery, and at 1 and 3 weeks after surgery.)
- Fatigue(Baseline, the day of surgery, and at 1 and 3 weeks after surgery.)
- Wound Healing at 1 week after surgery(1 week after surgery)