Peripheral Perfusion, Skin Oxygenation
Conditions
Keywords
Skin oxygenation, peripheral perfusion
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.
Interventions
OTHEROriginal Healing Salve (OHS)
Topical salve (Puremedy, Inc.)
OTHEROHS base only
Olive and beeswax salve base
Sponsors
National University of Natural Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous oxygen pressure (TcPO2) | 30 minutes | Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trend in TcPO2 | 0 to 30 minutes | Longitudinal trend in TcPO2 will be evaluated via measurements taken at 5 minutes intervals over 30 minutes |
Outcome results
None listed