Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction

NCT06634030 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 240597
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Healing; Surgical Wound

Keywords

Complex Surgical Defect; Skin Cancer Excision; Platelet-Derived Growth Factor

Outcome Measures

Primary Outcomes (1)

• Time-to-Readiness for Skin Graft in Days

  Time to 81-100% granulation of wounds as assessed by expert clinical review of photographs taken daily starting at day 7

  Daily, starting at day 7 up to day 56 following the baseline procedure

Secondary Outcomes (14)

• Granulation Rate

  Daily, starting at day 7 up to day 56 following the baseline procedure

• Change in Granulation on a 5-Point Scale

  Weekly, starting at week 1 up to week 8 following the baseline procedure

• Time to re-epithelialization

  Daily, starting at day 7 up to day 56 following the baseline procedure

• Re-epithelialization rate

  Daily, starting at day 7 up to day 56 following the baseline procedure

• Time to complete healing

  Daily, starting at day 7 up to day 56 following the baseline procedure

Study Arms (2)

Saline matrix

PLACEBO COMPARATOR

Participants receive wound matrix saturated with normal saline.

Drug: Saline

rhPDGF-BB matrix

EXPERIMENTAL

Participants receive wound matrix saturated with rhPDGF-BB.

Drug: RhPDGF-BB

Interventions

RhPDGF-BB DRUG

0.3 mg/mL rhPDGF-BB

rhPDGF-BB matrix

Saline DRUG

Normal saline

Saline matrix

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent surgery to completely remove skin cancer, either Mohs micrographic or wide local excision, that left a full-thickness surgical defect of the head or neck measuring between 1.5-10cm in greatest dimension with clear margins as assessed in the pathology report.
• Margins of the wound cannot be approximated or closed with stitches, sutures, staples, or glue
• Surgeon does not plan for immediate skin graft or flap
• Aged \>21 years old
• Willing and able to provide informed consent for study participation and compliance with study protocol
• Stated willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

• Medical conditions that would, in the opinion of the Investigator or treating provider, compromise the safety of the individual with study participation and/or the ability of the individual to follow study protocol
• The device will not fit the contour of the base of the wound bed
• Prior radiation therapy at the application site
• Known allergic reactions to porcine tissue, porcine collagen, or yeast-derived products
• Currently enrolled in a drug or device trial or within 30 days of last investigational drug or device administration at baseline visit where investigational treatment (drug or device) was placed in wound bed or may potentially interact with study treatment
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Lynch Regenerative Medicine, LLC: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (1)

• Younan SA, Ueland TE, Savitz BL, Jerome RN, Budine TD, Hawkins AT, Thayer WP, Wu DT, Lynch SE, Clark CR. Recombinant Platelet-Derived Growth Factor in Tissue Repair: A Review Exploring Frontiers in Regenerative Medicine. Plast Reconstr Surg. 2026 Apr 1;157(4):759-770. doi: 10.1097/PRS.0000000000012426. Epub 2025 Sep 15.

  PMID: 40952157 DERIVED

MeSH Terms

Conditions

Surgical Wound

Interventions

Becaplermin; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wesley P Thayer

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob J Smith

CONTACT

615-875-7466; jacob.smith@vumc.org

Cyndi R Clark, PhD

CONTACT

cyndi.r.clark@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research, Department of Plastic Surgery

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)