Arthritis Clinical Trials

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Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 yo or older

• Venous insufficiency documented on basis of Venous Insufficiency US or on basis of skin changes c/w stasis

• Ulcer location in area of stasis present on lower limb

• Ulcer surface greater or equal to 5 cm2 but no larger than 140 cm2 after the initial debridement

• Ankle brachial index (ABI) \> 0.8

• Ulcer duration longer than 4 weeks

• Pain scale assessment per visual analog scale at, or above, 2 at initial visit for the study

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Renea D Jennings, RN
Renea.Jennings@Advocatehealth.org
336-716-6709
Backup
Caleb Suggs
Caleb.Suggs@Advocatehealth.org
336-713-4339
Time Frame
Start Date: 2018-07-27
Estimated Completion Date: 2027-10
Participants
Target number of participants: 20
Treatments
Experimental: Laser Treatment
Summus Laser treatment with infrared light
Sham_comparator: Sham treatment
Sham Summus Laser treatment with no infrared light
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov