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The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis. The laser also causes a temporary increase in blood flow. The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.
The Summus Laser Cube is an FDA cleared light-emitting device for applying infrared to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
There will be a total of 20 subjects involved in this study. The study will only involve participants being treated at the Wake Forest University Health Sciences Wound Care Center. Ten participants will be randomized to the treatment arm and receive therapeutic laser therapy applied to the ulcer area. The other ten participants will receive a sham laser therapy, where the light emitted by the laser is visible, but not powerful enough to provide a therapeutic effect. During the first weekly visit, patients will have the wound debrided (dead or dying tissue will be removed),and the size of the ulcer measured and photographed. A wound dressing will be applied, followed by a compression wrap.
After one week patients will return to the Wound Care clinic and the size of the wound will be evaluated. If the wound has decreased by less than 30%,the patient will be randomized into the protocol. The patient will then have weekly visits, to include a survey, wound measurements, survey, photos,and laser treatments. The length of the study is a maximum of 17 weeks (less if the patient heals faster). The purpose of this study is to evaluate whether laser therapy can provide pain relief and speed the healing of venous leg ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment | Experimental | Summus Laser treatment with infrared light |
|
| Sham treatment | Sham Comparator | Sham Summus Laser treatment with no infrared light |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summus Laser | Device | infrared laser treatment |
| |
| Summus Laser Sham |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured by survey | Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable | up to 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Ulcer rate of healing | healing rate to denote the length of time the patient has a wound | up to 17 weeks |
| size of venous ulcer | wound measured length x width x depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renea D Jennings, RN | Contact | 336-716-6709 | rjenning@wakehealth.edu | |
| Caleb Suggs | Contact | 336-713-4339 | csuggs@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Molnar, MD | WFUHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Device |
non-infrared light |
|
| up to 17 weeks |
| Infectious complications | Number of events of infectious complications | up to 17 weeks |
| Wound aspect | % of granulation tissue | up to 17 weeks |
| Quality of Life Questionnaire | Quality of life questions, 0 no trouble or 5 severe trouble | up to 17 weeks |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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