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Venous Ulcers and Hyaluronic Acid Phonophoresis

31. maj 2026 opdateret af: Fatma Helmy Elmlegy, Cairo University

Enhancing Venous Ulcer Healing Via Hyaluronic Acid Phonophoresis: A Randomized Controlled Clinical Trial

Venous leg ulcers are severe manifestations of chronic venous insufficiency and account for a large proportion of lower limb ulcers. They typically occur below the knee, persist for more than six weeks, and are associated with significant impairment in quality of life and substantial socioeconomic burden. A major clinical challenge is their high recurrence rate, which can reach 50-70% within six months, making treatment resource-intensive and requiring multidisciplinary care. Therapeutic ultrasound and phonophoresis have been proposed to enhance wound healing by promoting tissue repair and improving transdermal drug delivery, including hyaluronic acid, which supports extracellular matrix restoration and wound healing. However, despite the theoretical advantages of combining ultrasound with hyaluronic acid, robust clinical evidence for its effectiveness in venous leg ulcers remains limited.

The study aimed to assess the effect of ultrasound-enhanced hyaluronic acid delivery on venous ulcer healing compared to ultrasound followed by topical application of hyaluronic acid.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study aimed to evaluate the efficacy of ultrasound-enhanced hyaluronic acid delivery (phonophoresis) on venous leg ulcer healing. The intervention group (Group A) received hyaluronic acid gel phonophoresis, whereas the comparator group (Group B) received ultrasound followed by topical application of hyaluronic acid gel. Outcomes were assessed after four weeks of treatment. The primary outcome was Percentage Wound Area Reduction (PWAR), defined as the change in wound area over the study period divided by time. The secondary outcomes were epithelialization rate and time-based healing rate.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

  • Egypten
      • Giza, Egypten
        • Outpatient Clinics of Faculty of Physical Therapy ,Cairo University.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Patients of both genders whose ages were between 30 - 70 years.

    • Patients with active venous ulcers (C6) according to CEAP (Clinical manifestations- Etiology- Anatomic distribution-Pathophysiology) classification.
    • clinically proved to be non-infected venous ulcers.
    • Patients receive the traditional physical therapy management for venous ulcers which includes compression therapy and active exercise plus frequent dressing change.
    • Patients suffering from recurrent or failed to heal venous ulcers.

Exclusion Criteria:

  • Individuals who were confined to bed with life-threatening conditions that could interfere with the study's objectives, such as myocardial infarction, renal failure or autoimmune diseases.
  • Patients who had hyaluronic acid hypersensitivity.
  • Presence of skin disorders or conditions that considered contraindicated for therapeutic US (e.g., cellulitis).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Study Group A
This group included 32 patients with venous ulcers who received combined treatment of topical hyaluronic acid gel and therapeutic ultrasound therapy, three sessions weekly for four weeks, in addition to the traditional physical therapy management including compression therapy and active ankle exercises.
Andet: Phonophoresis group (A)

For Study Group (A):

A layer of 0.2% topical hyaluronic acid gel was applied to cover and fill the wound cavity . A sterile glove filled with ultrasound gel was, then secured to the wound with surgical plaster, and ultrasound therapy was applied concurrently. The ultrasound was delivered for 1 minute per 1 cm² of the wound. The parameters used were 0.5 W/cm², low intensity, 1 MHz frequency, and pulsed mode with a 20% duty cycle, adjusted based on the ulcer size. The gel was removed, and the wound was dried and cleaned with saline and the US head with alcohol after each session. The treatment period lasted 4 weeks, with three sessions per week.
Eksperimentel: Study Group B
This group included 32 patients with venous ulcers who received ultrasound first then followed by topical hyaluronic acid, three sessions weekly for four weeks in addition to the traditional physical therapy management including compression therapy and active ankle exercises.
Andet: Ultrasound-preceded gel (hyaluronic acid gel) group (B):
Pulsed TUS was applied to the wound area at identical parameters to Group A (0.5 W/cm², 1 MHz, 20% duty cycle, one minute per cm²). Immediately following the TUS session, 0.2% HA gel was applied topically to the wound surface. Standard wound care was delivered as described for Group A. Treatment frequency and duration were identical to Group A.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Wound Area Reduction (PWAR)
Tidsramme: After 3 sessions per week for 4 weeks
It is calculated as: [(baseline wound area - post-treatment wound area) ÷ baseline wound area] × 100. Digital wound measurements were obtained at baseline and at week four using the validated imitoMeasure smartphone application (imito AG, Zurich, Switzerland). Standardized image acquisition procedures were followed, with the smartphone camera positioned 20-30 cm from the wound and maintained parallel to the wound surface. A calibration marker (QR code) was placed adjacent to the wound on the same plane before image capture, and a photo was taken once the app recognized the QR code. The operator delineated the wound borders on the photo using their finger then the app generated measurements of area, width, length, and circumference.
After 3 sessions per week for 4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Healing
Tidsramme: After 3 sessions per week for 4 weeks

The healing rate to assess the reduction in wound surface area (WSA) over a specified time interval.

The formula used was:

Healing Rate = Change in Wound Surface Area/ Time Period.

*(Change in WSA= Initial WSA - Final WSA). For this study, the healing rate was calculated over a 4-week period. Healing Rate per 4 Weeks = (WSA at Baseline - WSA at 4 Weeks) / 4. Digital wound measurements were obtained at baseline and at week four using the validated imitoMeasure smartphone application (imito AG, Zurich, Switzerland). Standardized image acquisition procedures were followed, with the smartphone camera positioned 20-30 cm from the wound and maintained parallel to the wound surface. A calibration marker (QR code) was placed adjacent to the wound on the same plane before image capture, and a photo was taken once the app recognized the QR code. The operator delineated the wound borders on the photo using their finger then the app generated measurements of area, width, length, and circumference
After 3 sessions per week for 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Efterforskere

  • Studieleder: HESHAM GALAL MAHRAN, Professor of PT, Faculty of Physical Therapy, department of physical therapy for surgery, Cairo University, Egypt
  • Studieleder: SHAIMAA MOHAMED ELSAYEH, Ass. Prof. of PT, Faculty of Physical Therapy, department of physical therapy for surgery, Cairo University, Egypt
  • Studieleder: WALIED MOHAMED KHEREBA, Prof. vascular surgery, Faculty of medicine, department of vascular and endovascular surgery, AL-Azhar University New Damietta, Egypt
  • Studieleder: Rasha S Farag, MSc, Damietta Directorate for Health Affairs

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2024

Primær færdiggørelse (Faktiske)

20. februar 2025

Studieafslutning (Faktiske)

26. februar 2025

Datoer for studieregistrering

Først indsendt

31. maj 2026

Først indsendt, der opfyldte QC-kriterier

31. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Hyaluronic acid phonophoresis

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality considerations, in accordance with institutional and ethical committee regulations governing patient data protection.

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