Vocal Fold Injection by Platelet Rich Plasma

January 11, 2026 updated by: Aya Esam Sharkawy, Assiut University

Efficacy of Platelet Rich Plasma Injection for Vocal Fold Sulcus, Scar and Atrophy

a study to asses safety and efficacy of platelet rich plasma injection in some types of vocal fold problems such as sulcus and atrophy to see the improvement in patient voice and its impact on patient quality of life with a good period of follow up

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vocal fold sulcus, atrophy and scarring are significant causes of dysphonia that present major therapeutic challenges for laryngologists. The etiology of vocal fold scarring is diverse, including phonotrauma, iatrogenic injury from phonomicrosurgery or intubation, malignancy, and radiation therapy. In addition, age-related changes such as the loss of hyaluronic acid, elastic fibers, and bulk causes atrophy can reduce the viable tissue mass.

Vocal fold atrophy leads to reduced pliability and impaired vibratory capacity of the vocal folds. Atrophy is commonly associated with aging (presbyphonia), but it may also result from denervation, disuse, or systemic conditions that affect muscle mass and extracellular matrix composition.

Sulcus vocalis is a structural vocal fold disorder characterized by the presence of a longitudinal furrow along the free edge of the vocal fold. It represents part of the spectrum of SLP disorders, as it involves abnormal thinning, tethering, or loss of the lamina propria, leading to reduced vibratory function. The condition can be congenital, due to defective vocal fold development, or acquired, often associated with chronic inflammation, phonotrauma, or previous vocal fold lesions.

Scarring, atrophy, and sulcus vocalis represent a spectrum of SLP disorders that share pathological features, including inflammatory changes, collagen dysregulation, and depletion of glycosaminoglycans such as hyaluronic acid. Unlike vocal fold paralysis where medialization techniques may restore glottic contact these conditions respond poorly to standard medialization procedures, as glottic gap is not the sole issue. Similarly, exogenous fillers may produce suboptimal vibratory characteristics due to differences in biomechanical properties between artificial materials and native SLP tissue.

These pathological changes primarily affect the superficial lamina propria (SLP) of the vocal folds, an essential layer that provides the viscoelasticity and tensile strength necessary for normal oscillation and sound production.

Disruption of the delicate collagen-elastin-hyaluronic acid balance within the SLP drastically reduces tissue compliance, leading to glottic insufficiency, irregular mucosal wave propagation, and impaired closure. Even minor architectural damage can significantly impact vocal quality, causing dysphonia, vocal fatigue, altered pitch, and decreased quality of life.

Glottic insufficiency due to bowing occurs when the loss of bulk causes the vocal folds to curve inward, leaving a spindle-shaped gap during phonation. This results in increased aperiodicity, as the thin and floppy folds lack sufficient mass and tension for regular vibration. To compensate, patients often engage extrinsic neck muscles to force the folds together, creating hyperfunction that produces a strained, effortful quality and masks the underlying flaccidity.

Current treatment strategies for SLP scarring include voice therapy as a first-line approach, often delivered by specialized speech-language pathologists. In cases with significant glottic insufficiency, surgical augmentation with autologous fat, fascia grafts, or inert injectable materials may be considered; however, these methods carry the risk of further impairing vibratory function. [ Platelet-rich plasma (PRP) has emerged as a promising, minimally invasive alternative. PRP is an autologous concentration of platelets in plasma, enriched with growth factors such as Platelet-erived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-beta (TGF-β), Hepatocyte Growth Facto (HGF), and basic Fibroblast Growth Factor (bFGF), which can stimulate angiogenesis, collagen remodeling, and tissue regeneration.

PRP exerts anti-inflammatory effects by suppressing signaling Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-κB ) signaling It has been safely applied across multiple fields, including orthopedics, dermatology, plastic surgery, and rheumatology, with low cost and no risk of immune rejection.[6]

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University
      • Asyut, Egypt
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1-Age ≥ 10 years 2-Gender: both sexes will be included in the study 3-clinical diagnosis of vocal fold sulcus, scar or atrophy. 4-Diagnosis confirmed by video laryngoscope examination. 5-be able to participate and sign informed consent.

Exclusion Criteria:

1- Laryngeal cancer. 2. Acute laryngeal infection . 3. Systemic diseases that may impair healing, such as:(Uncontrolled diabetes mellitus-Autoimmune disorders affecting the larynx-Coagulopathy or bleeding disorders).

4. Use of systemic corticosteroids or immunosuppressive drugs within the last 4 weeks.

5. Previous laryngeal surgery within the last 6 months 6. Pregnancy or lactation. 7. Known allergy or hypersensitivity to local anesthetics or any component used in PRP preparation.

8. Inability to complete with follow-up visits or voice assessment protocols

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: patients with vocal fold scar ,sulcus and atrophy
injection of platelet rich plasma in the vocal fold by special needle
Other: injection of platelet rich plasma
injection is done percutaneous using a special needle following the guides of surgical anatomy of the neck to reach the area of vocal folds under the effect of local anesthesia and by using nasofiberoscoby
Device: Nasofiberoscopy
It is a type of flexible endoscopies introduced from the patient nose to examine the entire airway reaching the larynx

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1-Subjective assessment of the patient using GRBAS scale 2- Subjective assessment of the patien by Arabic version of VHI •3- objective assessment of the patient using video stereoscopic examination and Acoustic analysis • 4-Improvement of patient voice
Time Frame: 4 years
Arabic version of VHI is a type of questionnaire the smaller score is the better result with a minimum value equal 0 and the maximum one equal 120,viedo stereoscopic examination is done by flexible nasofiberoscopy ,Acoustic analysis is a computerized system to measure different voice parameters ex fundamental frequency ,jitter and shimmer.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eman sayed hassan sayed eman hassan, professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • vocal fold injection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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