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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Placebo Comparator | Original Health Salve olive oil and beeswax base only without homeopathic or herbal extracts; acute effects only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Original Healing Salve (OHS) | Other | Topical salve (Puremedy, Inc.) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Transcutaneous oxygen pressure (TcPO2) | Change in TcPO2 will be compared between 0 min and 30 mins between Active and Placebo arms | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trend in TcPO2 | Longitudinal trend in TcPO2 will be evaluated via measurements taken at 5 minutes intervals over 30 minutes | 0 to 30 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10085972 | Background | Browne AC, Sibbald RG. The diabetic neuropathic ulcer: an overview. Ostomy Wound Manage. 1999 Jan;45(1A Suppl):6S-20S; quiz 21S-22S. | |
| 6481885 | 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. |
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| OHS base only |
| Other |
Olive and beeswax salve base |
|
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