Venous Leg UlcerNCT03716167
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
A study testing Summus Laser in people with Venous Leg Ulcer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Summus Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2018to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Renea D Jennings, RN, 336-716-6709, Renea.Jennings@Advocatehealth.org
Caleb Suggs, 336-713-4339, Caleb.Suggs@Advocatehealth.org
About this study
Official title: Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
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.
Read the detailed description
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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Summus Laser, Summus Laser Sham
- Keywords
- laser, ulcer, wound
- Medical subject headings
- Varicose Ulcer, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summus LaserDevice
infrared laser treatment
Summus Laser ShamDevice
non-infrared light
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Experimental | Summus Laser treatment with infrared light Receives: Device: Summus Laser |
| Sham treatment | Sham comparator | Sham Summus Laser treatment with no infrared light Receives: Device: Summus Laser Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured by survey
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable
Measured: up to 17 weeks
Secondary outcomes (5)
Venous Ulcer rate of healing
healing rate to denote the length of time the patient has a wound
Measured: up to 17 weeks
size of venous ulcer
wound measured length x width x depth
Measured: up to 17 weeks
Infectious complications
Number of events of infectious complications
Measured: up to 17 weeks
Wound aspect
% of granulation tissue
Measured: up to 17 weeks
Quality of Life Questionnaire
Quality of life questions, 0 no trouble or 5 severe trouble
Measured: up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start27 Jul 2018
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Molnar, MD, Principal investigator, WFUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716167
- Sponsor's protocol ID
- IRB00040491
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2018
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03716167
- Acronym / sponsor ID
- IRB00040491
- Conditions
- Venous Leg Ulcer
- Keywords
- laser, ulcer, wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Experimental | Device: Summus LaserSummus Laser treatment with infrared light |
| Sham treatment | Sham comparator | Device: Summus Laser ShamSham Summus Laser treatment with no infrared light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Summus Laserinfrared laser treatment | Device | Laser Treatment |
| Summus Laser Shamnon-infrared light | Device | Sham treatment |
Primary outcome
Pain measured by survey
Time frame: up to 17 weeks
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable
5 secondary outcomes
Venous Ulcer rate of healing
Time frame: up to 17 weeks
size of venous ulcer
Time frame: up to 17 weeks
Infectious complications
Time frame: up to 17 weeks
Wound aspect
Time frame: up to 17 weeks
Quality of Life Questionnaire
Time frame: up to 17 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Molnar, MD principal investigator
WFUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summus Laser in people with Venous Leg Ulcer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renea D Jennings, RN (336-716-6709, Renea.Jennings@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured by survey (time frame: up to 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.