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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

Primary Purpose

Venous Leg Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Summus Laser
Summus Laser Sham
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring laser, ulcer, wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser Treatment

Sham treatment

Arm Description

Summus Laser treatment with infrared light

Sham Summus Laser treatment with no infrared light

Outcomes

Primary Outcome Measures

Pain measured by survey
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable

Secondary Outcome Measures

Venous Ulcer rate of healing
healing rate to denote the length of time the patient has a wound
size of venous ulcer
wound measured length x width x depth
Infectious complications
Number of events of infectious complications
Wound aspect
% of granulation tissue
Quality of Life Questionnaire
Quality of life questions, 0 no trouble or 5 severe trouble

Full Information

First Posted
October 19, 2018
Last Updated
October 11, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03716167
Brief Title
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
Official Title
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2018 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
laser, ulcer, wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser Treatment
Arm Type
Experimental
Arm Description
Summus Laser treatment with infrared light
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Sham Summus Laser treatment with no infrared light
Intervention Type
Device
Intervention Name(s)
Summus Laser
Intervention Description
infrared laser treatment
Intervention Type
Device
Intervention Name(s)
Summus Laser Sham
Intervention Description
non-infrared light
Primary Outcome Measure Information:
Title
Pain measured by survey
Description
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable
Time Frame
up to 17 weeks
Secondary Outcome Measure Information:
Title
Venous Ulcer rate of healing
Description
healing rate to denote the length of time the patient has a wound
Time Frame
up to 17 weeks
Title
size of venous ulcer
Description
wound measured length x width x depth
Time Frame
up to 17 weeks
Title
Infectious complications
Description
Number of events of infectious complications
Time Frame
up to 17 weeks
Title
Wound aspect
Description
% of granulation tissue
Time Frame
up to 17 weeks
Title
Quality of Life Questionnaire
Description
Quality of life questions, 0 no trouble or 5 severe trouble
Time Frame
up to 17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renea D Jennings, RN
Phone
336-716-6709
Email
rjenning@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caleb Suggs
Phone
336-713-4339
Email
csuggs@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Molnar, MD
Organizational Affiliation
WFUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renea D Jennings, RN
Phone
336-716-6709
Email
rjenning@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Caleb Suggs
Phone
336-713-4339
Email
csuggs@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Joseph Molnar, MD
First Name & Middle Initial & Last Name & Degree
Lucian Vlad, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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