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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group A | Experimental | 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. |
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| Study Group B | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonophoresis group (A) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Wound Area Reduction (PWAR) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Healing | 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 |
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Inclusion Criteria:
Patients of both genders whose ages were between 30 - 70 years.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HESHAM GALAL MAHRAN, Professor of PT | Faculty of Physical Therapy, department of physical therapy for surgery, Cairo University, Egypt | Study Director |
| SHAIMAA MOHAMED ELSAYEH, Ass. Prof. of PT | Faculty of Physical Therapy, department of physical therapy for surgery, Cairo University, Egypt | Study Director |
| WALIED MOHAMED KHEREBA, Prof. vascular surgery | Faculty of medicine, department of vascular and endovascular surgery, AL-Azhar University New Damietta, Egypt | Study Director |
| Rasha S Farag, MSc | Damietta Directorate for Health Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinics of Faculty of Physical Therapy ,Cairo University. | Giza | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | https://www.mdpi.com/2077-0383/11/3/537 | ||
| Background | https://www.mdpi.com/2073-4409/11/15/2439 | ||
| 29487767 | Background | Alkahtani SA, Kunwar PS, Jalilifar M, Rashidi S, Yadollahpour A. Ultrasound-based Techniques as Alternative Treatments for Chronic Wounds: A Comprehensive Review of Clinical Applications. Cureus. 2017 Dec 15;9(12):e1952. doi: 10.7759/cureus.1952. | |
| 33997567 |
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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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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Ultrasound-preceded gel (hyaluronic acid gel) group (B): | Other | 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. |
|
| After 3 sessions per week for 4 weeks |
| Background |
| Biagioni RB, Carvalho BV, Manzioni R, Matielo MF, Brochado Neto FC, Sacilotto R. Smartphone application for wound area measurement in clinical practice. J Vasc Surg Cases Innov Tech. 2021 Feb 26;7(2):258-261. doi: 10.1016/j.jvscit.2021.02.008. eCollection 2021 Jun. |
| 33374372 | Background | Raffetto JD, Ligi D, Maniscalco R, Khalil RA, Mannello F. Why Venous Leg Ulcers Have Difficulty Healing: Overview on Pathophysiology, Clinical Consequences, and Treatment. J Clin Med. 2020 Dec 24;10(1):29. doi: 10.3390/jcm10010029. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |