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Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy

Wake Forest University Health Sciences · NCT03716167

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
July 27, 2018
Record last updated
July 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Summus Laser; Summus Laser Sham

Conditions: Venous Leg Ulcer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Wake Forest University Health Sciences

    Winston-Salem, NC 27157

    Site contact: Renea D Jennings, RN · 336-716-6709 · Renea.Jennings@Advocatehealth.org

Study contacts (from the official record)

  • Renea D Jennings, RN · 336-716-6709 · Renea.Jennings@Advocatehealth.org
  • Caleb Suggs · 336-713-4339 · Caleb.Suggs@Advocatehealth.org
All healthy volunteers studies in North Carolina →
Randomized Controlled Trial for Treatment of Pain and Assessment… (NCT03716167) | Bored Studies