Effects of Topical Herbal Salve on Cutaneous Oxygenation and Peripheral Blood Flow
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Transcutaneous oxygen pressure (TcPO2)
研究概览
简要总结
Delayed wound healing leads to increased risk for infection, and thus increased risk for morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound healing. The investigators will conduct a double-masked, placebo-controlled cross-over clinical pilot trial in order to evaluate the effects of a topical, homeopathic/herbal salve (Original Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow.
详细描述
Delayed wound healing leads to increased risk for infection, and thus increased risk for morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound healing. In order to evaluate the effects of a topical, homeopathic/herbal salve (Original Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow, the investigators will conduct a double-masked, placebo-controlled cross-over clinical pilot trial with randomized testing order to evaluate the effects of the salve on cutaneous oxygen saturation (TcPO2) and ankle-to-brachial pressure index (ABPI). The investigators will recruit thirty-two participants in two cohorts to participate, one with and one without type 2 diabetes, who are otherwise generally healthy without active wounds, ulcers or skin rashes. Both TcPO2 and ABPI will be measured before and after the application of both the homeopathic/herbal salve ("active"), and before and after the application of the inert salve base ("placebo"). Analyses will compare pre/post changes in TcPO2 and ABPI before and after application of the active salve within the same visit, and also compare the changes from the active salve to the before and after changes in TcPO2 and ABPI measured from the placebo salve. If the Original Healing Salve improves cutaneous oxygenation and/or ABPI, future research may evaluate the formula specifically for wound healing and antimicrobial effects. Thus the proposed research is a pilot study targeting mechanistic outcomes, which predict potential clinical efficacy. The proposed research is significant, as lower cost, more effective treatments are needed to improve wound healing and reduce the morbidity associated with the complications of delayed wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes without known complications, i.e., eye damage (retinopathy), nerve damage (diabetic peripheral neuropathy), kidney damage (diabetic kidney disease), or heart damage (recent myocardial infarction or severe congestive heart failure)
- •Age ≥ 18 and ≤ 75
- •Willing and able to give informed consent
- •Able to follow protocol and attend visits
- •Able to read and write English
排除标准
- •Active malignancy, excluding basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix. If present, dermal cancers may not be located on or around the testing sites.
- •A recent cardiovascular event (e.g., myocardial infarction, stroke ≤ six months prior to screening visit), current coronary artery disease, angina, stage III or IV congestive heart failure, or stated history of coronary bypass surgery or heart stent placement.
- •Current active diabetic ulcers.
- •History of diabetic neuropathy.
- •Diagnosis of type 2 diabetes for longer than 10 years.
- •Diagnosis of type 1 diabetes.
- •Established diagnosis of peripheral artery disease (PAD) or intermittent claudication.
- •Established diagnosis of peripheral venous disease (PVD) or chronic venous insufficiency.
- •Active rash, wound, or ulcer on lower leg, including psoriasis or eczema.
- •Presence of edema > +1; pitting or non pitting.
- •Currently taking any of the following beta-blocker medications (due to potential impact on peripheral vasodilation): acebutolol (Sectral®), atenolol (Tenormin®), betaxolol (Kerlone®), bisoprolol fumarate (Zebeta®, Ziac®), carvedilol (Coreg®),metoprolol (Lopressor®, Toprol XL®), nadolol (Corgard®), nebivolol (Bystolic®), penbutolol (Levatol®), propranolol (Hemangeol®, Inderal LA® Inderal XL®, InnoPran XL®), esmolol (Brevibloc), sotalol (Betapace, Sorine), labetalol (Normodyne, Trandate), pindolol (Visken).
- •Currently taking any of the following cholinergic medications (due to potential impact on peripheral vasodilation): acetylcholine, atropine, bethanechol (Urecholine®), donepezil (Aricept®), ipratropium bromide (Atrovent®), neostigmine (Prostigmine®), nicotine (Nicoderm®, Nicotrol®), oxybutynin (Ditropan®), physostigmine, pilocarpine (Salagen®), pralidoxime (Protopam®), succinylcholine (Anectine®), tiotropium bromide (Spiriva®, Tiova®), tolterodine (Detrol®), vecuronium (Norcuron®).
- •Allergy to any ingredient found in the study products: pine resin, balsam fir resin, elder (Sambucus) flower and bark, marigold (Calendula), cone flower (Echinacea), olive oil, safflower oil or beeswax.
- •Walking Impairment Questionnaire Speed Scores between 0-18 due to risk for PAD (21).
- •Walking Impairment Questionnaire Distance Scores between 0-19 due to risk for PAD (21).
- •Presence of an unstable and/or significant medical disorder that would compromise the participant's safety to take part in the trial.
- •Use of tobacco products, e-cigarettes, nicotine patches and/or nicotine gum
- •Scleroderma
- •Raynaud's
- •Planned elective surgery within the next 6 weeks
- •Pregnant, nursing, or planning a pregnancy within the next 6 weeks
结局指标
主要结局
Transcutaneous oxygen pressure (TcPO2)
时间窗: 30 minutes
Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms
次要结局
- Ankle-to-Brachial Pressure Index (ABPI)(30 minutes)
研究者
Ryan Bradley
Associate Professor
National University of Natural Medicine