Comparing non-contact ultrasound to standard care for fingertip injuries
Enhancing Healing With Non-Contact Low-Frequency Ultrasound in Fingertip Amputation Treatment: A Prospective Comparative Cohort Study
NA · St. Luke's Hospital, Pennsylvania · NCT06813430
This study is testing whether a new non-contact ultrasound treatment can help people with fingertip amputations heal better than the usual care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Luke's Hospital, Pennsylvania (other) |
| Locations | 1 site (Bethlehem, Pennsylvania) |
| Trial ID | NCT06813430 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of non-contact low frequency ultrasound in improving healing outcomes for patients with acute fingertip amputations. Participants will be randomly assigned to receive either the non-contact ultrasound treatment or the standard Lalonde protocol. They will undergo therapy sessions 2-3 times per week, with weekly assessments of wound size to determine healing progress. The study seeks to address the gap in research regarding the use of this innovative ultrasound technology for acute injuries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute fingertip amputations that do not involve exposed bone or tendons.
Not a fit: Patients with exposed bone, those under 18 years old, or individuals with infections or vascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes for patients with fingertip amputations.
How similar studies have performed: While there is some evidence supporting the use of non-contact low frequency ultrasound for chronic wounds, its application for acute fingertip injuries is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18 years or older with an acute traumatic fingertip amputation without exposed bone or tendons (Allen 1, Tamai level 1; ICD-10 codes S68.5 and S68.6). Exclusion Criteria: * Patients less than 18 years old, * Injuries involving exposed bone * Those with diagnosis of vascular disease * Individuals with clinical suspicion or diagnosis of infection * Unable to comply with prescribed therapy sessions * Patients undergoing primary closure or surgical intervention * Patients experiencing subsequent trauma following treatment initiation
Where this trial is running
Bethlehem, Pennsylvania
- St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Kristofer Matullo, MD
- Email: Kristofer.Matullo@sluhn.org
- Phone: 484-526-1735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-contact Low Frequency Ultrasound, Lalonde Protocol, Fingertip Amputation, non-contact low frequency ultrasound, Lalonde protocol, fingertip amputation