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NCT06634030 · ClinicalTrials.gov registry record · Phase 2
Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
A Phase 2 study of Surgical Wound and Wound Healing, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06634030: Recruiting Phase 2 study of Surgical Wound and Wound Healing, sponsored by Vanderbilt University Medical Center.
NCT06634030 is a Phase 2 study of Surgical Wound and Wound Healing that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants, below the 93-participant average among 17 other Surgical Wound trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06634030, a Phase 2 study of Surgical Wound and Wound Healing, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large defects requiring reconstruction to restore function and aesthetics. Rotational flaps and free flaps are techniques used to reconstruct large, complex defects that cannot be closed with sutures, staples, or glue. Older, frail patients are particularly vulnerable to complications from these procedures often leaving them to care for chronic wounds until a skin graft can be placed. Phenome-wide association studies (PheWAS) revealed a cohort of patients with a single nucleotide variant (SNV) in PDGFRβ having a higher incidence of chronic skin ulcers, skin grafts, and other skin and connective tissue disorders suggesting that the loss of PDGFβ signaling may impair healing following trauma. rhPDGF-BB, a recombinant human platelet derived growth factor protein-based therapy, signals through PDGFRβ to mediate inflammation, granulation, angiogenesis, and remodeling during wound healing and skin repair and is FDA cleared for diabetic neuropathic ulcers and periodontal bone and soft tissue reconstructions. These data suggest rhPDGF-BB may be a viable therapeutic strategy to augment the reconstruction of these complex defects by accelerating granulation, epithelialization, and wound closure.
Primary Outcome
Time to 81-100% granulation of wounds as assessed by expert clinical review of photographs taken daily starting at day 7
Conditions Studied
Interventions
- DRUG Saline
- DRUG RhPDGF-BB
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06634030 shows while recruiting
NCT06634030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 93-participant average among 17 other Surgical Wound trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Surgical Wound appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT06634030 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06634030 about?
NCT06634030 is a clinical study titled "Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction". Skin cancers such as basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma lesions that develop on the head and neck are treated by Mohs surgery or wide local excision to remove all tumor cells and preserve the normal tissue. These surgical techniques may result in large defects re...
What is the current status of trial NCT06634030?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-04-01. Estimated completion is 2026-06.
What conditions does trial NCT06634030 study?
This clinical trial studies the following conditions: Surgical Wound, Wound Healing.
What interventions are being tested in trial NCT06634030?
The interventions under investigation include: Saline (DRUG), RhPDGF-BB (DRUG).
Who is sponsoring clinical trial NCT06634030?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06634030 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Wound
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06634030's enrollment target sits among peer trials
40 12th of 17 higher than 5 of 17 other Surgical Wound trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Wound trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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