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Eine Studie entspricht den Filterkriterien
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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

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT03716167 ist eine interventionsstudie zur Untersuchung von Venöses Beingeschwür und hat den Status offene rekrutierung. Die Studie startete am 27. Juli 2018 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Wake Forest University ist der Abschluss für 1. Oktober 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 28. August 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

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

Erkrankungen
Venöses Beingeschwür
Weitere Studien-IDs
  • IRB00040491
NCT-Nummer
Studienbeginn (tatsächlich)
2018-07-27
Zuletzt aktualisiert
2025-08-28
Studienende (vorauss.)
2026-10
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
laser
ulcer
wound
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellLaser Treatment
Summus Laser treatment with infrared light
Summus Laser
infrared laser treatment
Schein-VergleichspräparatSham treatment
Sham Summus Laser treatment with no infrared light
Summus Laser Sham
non-infrared light
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Pain measured by survey
Survey of 0-10, with 0 being no pain and 10 being the worst pain imaginable
up to 17 weeks
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Venous Ulcer rate of healing
healing rate to denote the length of time the patient has a wound
up to 17 weeks
size of venous ulcer
wound measured length x width x depth
up to 17 weeks
Infectious complications
Number of events of infectious complications
up to 17 weeks
Wound aspect
% of granulation tissue
up to 17 weeks
Quality of Life Questionnaire
Quality of life questions, 0 no trouble or 5 severe trouble
up to 17 weeks
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • 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

  • 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.
Zentrale Studienkontakte
Kontakt: Renea D Jennings, RN, 336-716-6709, [email protected]
Kontakt: Caleb Suggs, 336-713-4339, [email protected]
1 Studienstandorte in 1 Ländern

North Carolina

Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States
Renea D Jennings, RN, Kontakt, 336-716-6709, [email protected]
Caleb Suggs, Kontakt, 336-713-4339, [email protected]
Joseph Molnar, MD, Hauptprüfer
Lucian Vlad, MD, Hauptprüfer
Offene Rekrutierung