Topical Salve for Skin Oxygenation and Blood Flow (OHS)

November 6, 2018 updated by: Ryan Bradley, National University of Natural Medicine

Effects of Topical Herbal Salve on Cutaneous Oxygenation and Peripheral Blood Flow

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
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
Other: Original Healing Salve (OHS)
Topical salve (Puremedy, Inc.)
Placebo Comparator: Control
Original Health Salve olive oil and beeswax base only without homeopathic or herbal extracts; acute effects only
Other: OHS base only
Olive and beeswax salve base

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous oxygen pressure (TcPO2)
Time Frame: 30 minutes
Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle-to-Brachial Pressure Index (ABPI)
Time Frame: 30 minutes
Change in ABPI will be compared between 0 min and 30 mins between Active and Placebo arms
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trend in TcPO2
Time Frame: 0 to 30 minutes
Longitudinal trend in TcPO2 will be evaluated via measurements taken at 5 minutes intervals over 30 minutes
0 to 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Natural Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01202015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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