Topical Salve for Skin Oxygenation and Blood Flow

Phase 2

Completed

• Conditions: Peripheral Perfusion; Skin Oxygenation
• Interventions: Other: Original Healing Salve (OHS); Other: OHS base only

• Registration Number: NCT02394366
• Lead Sponsor: National University of Natural Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Original Healing Salve (OHS)	Original Healing Salve (Puremedy, Inc.) including 1x homeopathic dilutions of Calendula, Echinacea, and Sambucus extracts, plus extracts from pine and Balsam fir; acute effects only
Control	OHS base only	Original Health Salve olive oil and beeswax base only without homeopathic or herbal extracts; acute effects only

Primary Outcome Measures

Name	Time	Method
Transcutaneous oxygen pressure (TcPO2)	30 minutes	Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms

Secondary Outcome Measures

Name	Time	Method
Ankle-to-Brachial Pressure Index (ABPI)	30 minutes	Change in ABPI will be compared between 0 min and 30 mins between Active and Placebo arms