Peripheral Perfusion Clinical Trial
— OHSOfficial title:
Effects of Topical Herbal Salve on Cutaneous Oxygenation and Peripheral Blood Flow
NCT number | NCT02394366 |
Other study ID # | 01202015 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | October 2015 |
Verified date | November 2018 |
Source | National University of Natural Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National University of Natural Medicine |
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Duran V, Matic M, Jovanovc M, Mimica N, Gajinov Z, Poljacki M, Boza P. Results of the clinical examination of an ointment with marigold (Calendula officinalis) extract in the treatment of venous leg ulcers. Int J Tissue React. 2005;27(3):101-6. — View Citation
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Khmel'nitskii OK, Simbirtsev AS, Konusova VG, McHedlidze GSh, Fidarov EZ, Paramonov BA, Chebotarev VY. Pine resin and Biopin ointment: effects on cell composition and histochemical changes in wounds. Bull Exp Biol Med. 2002 Jun;133(6):583-5. — View Citation
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White RA, Nolan L, Harley D, Long J, Klein S, Tremper K, Nelson R, Tabrisky J, Shoemaker W. Noninvasive evaluation of peripheral vascular disease using transcutaneous oxygen tension. Am J Surg. 1982 Jul;144(1):68-75. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Trend in TcPO2 | Longitudinal trend in TcPO2 will be evaluated via measurements taken at 5 minutes intervals over 30 minutes | 0 to 30 minutes | |
Primary | Transcutaneous oxygen pressure (TcPO2) | Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms | 30 minutes | |
Secondary | Ankle-to-Brachial Pressure Index (ABPI) | Change in ABPI will be compared between 0 min and 30 mins between Active and Placebo arms | 30 minutes |
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