Topical Salve for Skin Oxygenation and Blood Flow

NCT02394366 | Completed Phase 2

• 1 other identifier: 01202015
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Oxygenation; Peripheral Perfusion

Keywords

Skin oxygenation; peripheral perfusion

Outcome Measures

Primary Outcomes (1)

• Transcutaneous oxygen pressure (TcPO2)

  Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms

  30 minutes

Secondary Outcomes (1)

• Ankle-to-Brachial Pressure Index (ABPI)

  30 minutes

Other Outcomes (1)

• Trend in TcPO2

  0 to 30 minutes

Study Arms (2)

Active

EXPERIMENTAL

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)

Control

PLACEBO COMPARATOR

Original Health Salve olive oil and beeswax base only without homeopathic or herbal extracts; acute effects only

Other: OHS base only

Interventions

Original Healing Salve (OHS) OTHER

Topical salve (Puremedy, Inc.)

Active

OHS base only OTHER

Olive and beeswax salve base

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National University of Natural Medicine: lead

Related Publications (20)

• Browne AC, Sibbald RG. The diabetic neuropathic ulcer: an overview. Ostomy Wound Manage. 1999 Jan;45(1A Suppl):6S-20S; quiz 21S-22S.

  PMID: 10085972 BACKGROUND

• Cina C, Katsamouris A, Megerman J, Brewster DC, Strayhorn EC, Robison JG, Abbott WM. Utility of transcutaneous oxygen tension measurements in peripheral arterial occlusive disease. J Vasc Surg. 1984 Mar;1(2):362-71. doi: 10.1067/mva.1984.avs0010362.

  PMID: 6481885 BACKGROUND

• Blake DF, Young DA, Brown LH. Transcutaneous oximetry: normal values for the lower limb. Diving Hyperb Med. 2014 Sep;44(3):146-53.

  PMID: 25311321 BACKGROUND

• Andrews KL, Dib MY, Shives TC, Hoskin TL, Liedl DA, Boon AJ. Noninvasive arterial studies including transcutaneous oxygen pressure measurements with the limbs elevated or dependent to predict healing after partial foot amputation. Am J Phys Med Rehabil. 2013 May;92(5):385-92. doi: 10.1097/PHM.0b013e3182876a06.

  PMID: 23478457 BACKGROUND

• Reddy KK, Grossman L, Rogers GS. Common complementary and alternative therapies with potential use in dermatologic surgery: risks and benefits. J Am Acad Dermatol. 2013 Apr;68(4):e127-e135. doi: 10.1016/j.jaad.2011.06.030. Epub 2011 Sep 3.

  PMID: 21890235 BACKGROUND

• Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14. doi: 10.1086/657912.

  PMID: 21460463 BACKGROUND

• Cesarone MR, Belcaro G, Rohdewald P, Pellegrini L, Ledda A, Vinciguerra G, Ricci A, Ippolito E, Fano F, Dugall M, Cacchio M, Di Renzo A, Hosoi M, Stuard S, Corsi M. Improvement of signs and symptoms of chronic venous insufficiency and microangiopathy with Pycnogenol: a prospective, controlled study. Phytomedicine. 2010 Sep;17(11):835-9. doi: 10.1016/j.phymed.2010.04.009. Epub 2010 Jun 25.

  PMID: 20579863 BACKGROUND

• Fife CE, Smart DR, Sheffield PJ, Hopf HW, Hawkins G, Clarke D. Transcutaneous oximetry in clinical practice: consensus statements from an expert panel based on evidence. Undersea Hyperb Med. 2009 Jan-Feb;36(1):43-53.

  PMID: 19341127 BACKGROUND

• Aboyans V, Ho E, Denenberg JO, Ho LA, Natarajan L, Criqui MH. The association between elevated ankle systolic pressures and peripheral occlusive arterial disease in diabetic and nondiabetic subjects. J Vasc Surg. 2008 Nov;48(5):1197-203. doi: 10.1016/j.jvs.2008.06.005. Epub 2008 Aug 9.

  PMID: 18692981 BACKGROUND

• Mathieu D, Mani R. A review of the clinical significance of tissue hypoxia measurements in lower extremity wound management. Int J Low Extrem Wounds. 2007 Dec;6(4):273-83. doi: 10.1177/1534734607310299.

  PMID: 18048873 BACKGROUND

• Humphreys ML, Stewart AH, Gohel MS, Taylor M, Whyman MR, Poskitt KR. Management of mixed arterial and venous leg ulcers. Br J Surg. 2007 Sep;94(9):1104-7. doi: 10.1002/bjs.5757.

  PMID: 17497654 BACKGROUND

• Belcaro G, Cesarone MR, Errichi BM, Ledda A, Di Renzo A, Stuard S, Dugall M, Pellegrini L, Gizzi G, Rohdewald P, Ippolito E, Ricci A, Cacchio M, Cipollone G, Ruffini I, Fano F, Hosoi M. Diabetic ulcers: microcirculatory improvement and faster healing with pycnogenol. Clin Appl Thromb Hemost. 2006 Jul;12(3):318-23. doi: 10.1177/1076029606290133.

  PMID: 16959685 BACKGROUND

• 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.

  PMID: 16372475 BACKGROUND

• 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. doi: 10.1023/a:1020290010605.

  PMID: 12447472 BACKGROUND

• McDermott MM, Liu K, Guralnik JM, Martin GJ, Criqui MH, Greenland P. Measurement of walking endurance and walking velocity with questionnaire: validation of the walking impairment questionnaire in men and women with peripheral arterial disease. J Vasc Surg. 1998 Dec;28(6):1072-81. doi: 10.1016/s0741-5214(98)70034-5.

  PMID: 9845659 BACKGROUND

• Conlon KC, Sclafani L, DiResta GR, Brennan MF. Comparison of transcutaneous oximetry and laser Doppler flowmetry as noninvasive predictors of wound healing after excision of extremity soft-tissue sarcomas. Surgery. 1994 Mar;115(3):335-40.

  PMID: 8128357 BACKGROUND

• 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. doi: 10.1016/0002-9610(82)90604-3.

  PMID: 7091534 BACKGROUND

• Ratliff DA, Clyne CA, Chant AD, Webster JH. Prediction of amputation wound healing: the role of transcutaneous pO2 assessment. Br J Surg. 1984 Mar;71(3):219-22. doi: 10.1002/bjs.1800710320.

  PMID: 6697129 BACKGROUND

• Karanfilian RG, Lynch TG, Zirul VT, Padberg FT, Jamil Z, Hobson RW 2nd. The value of laser Doppler velocimetry and transcutaneous oxygen tension determination in predicting healing of ischemic forefoot ulcerations and amputations in diabetic and nondiabetic patients. J Vasc Surg. 1986 Nov;4(5):511-6.

  PMID: 2945936 BACKGROUND

• Kram HB, Appel PL, Shoemaker WC. Multisensor transcutaneous oximetric mapping to predict below-knee amputation wound healing: use of a critical Po2. J Vasc Surg. 1989 Jun;9(6):796-800. doi: 10.1067/mva.1989.vs0090796.

  PMID: 2657122 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 20, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 8, 2018

Record last verified: 2018-11