Using laser therapy to treat pain and promote healing in chronic venous leg ulcers
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
This study is testing if laser therapy can help relieve pain and speed up healing for people with chronic venous leg ulcers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT03716167 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of near-infrared laser therapy in providing pain relief and enhancing wound healing in patients with chronic venous leg ulcers. A total of 20 participants will be enrolled, with half receiving actual laser treatment and the other half receiving a sham treatment. Participants will undergo weekly assessments, including wound measurements and surveys, over a maximum duration of 17 weeks. The study aims to determine if laser therapy can significantly improve healing outcomes compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with chronic venous leg ulcers that have persisted for more than four weeks.
Not a fit: Patients with autoimmune disorders, recent venous ablation, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a non-invasive option for pain relief and faster healing of venous leg ulcers.
How similar studies have performed: Other studies have shown promising results with laser therapy for wound healing, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant, nursing or child bearing potential * Venous ablation past 6 weeks and duration of study * Autoimmune disorder * Immune suppressive meds, Including steroids * Any other co-playing comorbidities into wound etiology (neuropathy with pressure reinjury or uncontrolled diabetes with Hb A1c \> 9) * Use of bioengineered products 30 days before and during the duration of study * 15\<BMI \<50 * Use of oral or IV administered antibiotics within one week prior to randomization * Having tattoos in the region of skin above or adjacent to the ulcer where laser light might be applied.
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Molnar, MD — Wfuhs
- Study coordinator: Renea D Jennings, RN
- Email: rjenning@wakehealth.edu
- Phone: 336-716-6709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.