Wound HealingPhase 2NCT06634030
Evaluating rhPDGF-BB-Enhanced Wound Matrix for Head and Neck Reconstruction
A Phase 2 study testing RhPDGF-BB and Saline in people with Wound Healing and Surgical Wound, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Wound Healing, Surgical Wound
- What is being tested?
- RhPDGF-BB and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 15 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Evidence of current clinical infection as demonstrated by the invasion of bacteria into the healthy viable tissue on the periphery of the wound (colonization of wound bed due to normal flora or environment is not exclusionary)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: A Randomized, Double-Blinded, Controlled Trial Evaluating Recombinant Human Platelet-Derived Growth Factor B (rhPDGF-BB)-Enhanced Wound Matrix in the Reconstruction of Full-Thickness Head or Neck Defects Following Skin Cancer Excision
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.
Read the detailed description
This Phase II clinical trial will evaluate the potential efficacy of rhPDGF-BB-enhanced wound matrix versus wound matrix saturated with normal saline to augment healing of head and neck defects that cannot be healed by primary intention following skin cancer excision. This prospective, double-blinded, single-site study will randomize participants into two arms - intervention and control - comparing the granulation, re-epithelialization, complete healing, and scarring of the wound bed, pain, and quality of life. After recruiting, consenting, and screening, participants will undergo the baseline procedure to place the wound matrix into the wound bed. Randomization will occur immediately before the baseline procedure, and both the PI and participant will be blinded. To achieve balance in treatment allocation, randomization blocks of 4 (2 interventions : 2 controls) will be stratified by anatomical location, scalp versus face/neck, and greatest dimension, < 3cm versus > 3cm, of the surgical defect. Following the baseline procedure, participants will return for their first follow-up visit on day 6 for a clinical examination, suture removal, and wound dressing change, and then again at weeks 4 and 8 for a clinical exam and photographs. Pain and adverse events will be evaluated and documented weekly through the participants' electronic health records, phone call, email survey, or in-person. Participants will submit daily photographs of the wound while performing dressing changes at home starting on day 7 until day 56. These photographs will be taken using a wound imaging application that will be downloaded to a personal mobile device with assistance from the study coordinator. Each patient will also receive a hard copy of instructions for using the application at home. The mobile application can ensure quality photographs and transfer the images to a password-protected cloud-based portal. The photographs will be analyzed by blinded wound experts, retrospectively, to determine the precise day that the wound bed achieved 81-100% granulation. The imaging software will also be used to trace and measure the rate of healing by granulation, re-epithelialization, and wound closure. Under routine care with a wound matrix (no rhPDGF-BB), the average time to granulation is 4-6 weeks in this patient population. Here, we aim to reduce the time to readiness by adding rhPDGF-BB. It is expected that all participants will complete the study which begins at time of signing informed consent and ends at the final study follow-up visit.
- Conditions
- Wound Healing, Surgical Wound
- Being tested
- RhPDGF-BB, Saline
- Keywords
- Complex Surgical Defect, Skin Cancer Excision, Platelet-Derived Growth Factor
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhPDGF-BBDrug
0.3 mg/mL rhPDGF-BB
SalineDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Saline matrix | Placebo comparator | Participants receive wound matrix saturated with normal saline. Receives: Drug: Saline |
| rhPDGF-BB matrix | Experimental | Participants receive wound matrix saturated with rhPDGF-BB. Receives: Drug: RhPDGF-BB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Daily, starting at day 7 up to day 56 following the baseline procedure
Secondary outcomes (14)
Granulation Rate
Percent granulation versus time in days as determined by clinical assessment of the percent granulation of the wound bed in photographic images taken daily starting at day 7 following the baseline procedure.
Measured: Daily, starting at day 7 up to day 56 following the baseline procedure
Change in Granulation on a 5-Point Scale
Weekly ordinal scale outcomes of granulation as determined by clinical review of wound bed granulation in photographs taken daily starting at day 7 following the baseline procedure. Ordinal scale ranges from 1 to 5 in the increments below.
- 0-20% granulation = 1
- 21-40% granulation = 2
- 41-60% granulation = 3
- 61-80% granulation = 4
- 81-100% = 5
Measured: Weekly, starting at week 1 up to week 8 following the baseline procedure
Time to re-epithelialization
Time to 100% re-epithelialization as assessed by expert clinicians utilizing the NetHealth Tissue Analytics software to measure the percent of new epithelial tissue formed on the wound in daily photographs
Measured: Daily, starting at day 7 up to day 56 following the baseline procedure
Re-epithelialization rate
Percent re-epithelialization versus time as assessed by expert clinicians utilizing the NetHealth Tissue Analytics software to measure the percent of new epithelial tissue formed on the wound in daily photographs
Measured: Daily, starting at day 7 up to day 56 following the baseline procedure
Time to complete healing
Time to complete healing as assessed by expert clinicians utilizing the NetHealth Tissue Analytics software to measure wound closure in daily photographs
Measured: Daily, starting at day 7 up to day 56 following the baseline procedure
Healing rate
Wound size change over time to as assessed by expert clinicians utilizing the NetHealth Tissue Analytics software to measure wound closure in daily photographs
Measured: Daily, starting at day 7 up to day 56 following the baseline procedure
Aesthetics Rating at Week 8
Aesthetics rating of the wound as assessed by clinical examination at the final week 8 follow-up visit using an ordinal scale from 0 (very ugly) to 10 (very nice).
Measured: Week 8
Scar Scale at Week 8
Scar rating of the wound as assessed by clinical examination at the final week 8 follow-up visit, with rating determined by the score on the Manchester Scar Scale. This score is calculated from four ordinal scales that range from 1-4, with 1 indicating a better scar and 4 indicating a worse scar.
Measured: Week 8
Change from Baseline in Pain on an 11-Point Scale
Weekly self-reported participant surveys will assess average pain intensity on an 11-point scale. Possible scores range from 0 (No Pain) to 10 (Worst Pain).
Measured: From enrollment through week 8
Change from Baseline in Quality of Life
Change in quality of life based on a self-reported 12-question survey taken at baseline and at week 8.
Measured: From enrollment through week 8
Number of Participants Recruited and Eligible
Total number of participants that were recruited and eligible for the study.
Measured: Monthly up to month 15
Number of Participants Randomized Per Month
Number of participants that were randomized each month of the study.
Measured: Monthly up to month 15
Proportion of Participants Retained at Week 8
Proportion of participants retained in the study at week 8 (end of study).
Measured: Week 8
Weekly Percentage of Completed Daily Photos at Week 8
Participant adherence to daily wound photograph schedule.
Measured: Weekly, week 1 up to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Apr 2025
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lynch Regenerative Medicine
- Responsible party
- Principal investigator, Wesley Self, Vanderbilt University Medical Center
- Investigators
- Wesley Self, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634030
- Sponsor's protocol ID
- 240597
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clark CR, Blette BS, Guzman RAT, Lempicki MD, Karamitros G, Gergoudis F, Gutama BW, O'Neill DR, Savitz B, Smith J, Shirey-Rice JK, Pulley JM, Lynch SE, McGonigle TW, Thayer WP. Study protocol and statistical analysis plan for a randomized, double-blind, controlled trial evaluating recombinant human platelet-derived growth factor B (rhPDGF) in the reconstruction of complex head or neck defects following skin cancer excision. medRxiv [Preprint]. 2026 May 4:2026.05.01.26352276. doi: 10.64898/2026.05.01.26352276.
PubMed 42145621Younan 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.
PubMed 40952157
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Controlled Trial Evaluating Recombinant Human Platelet-Derived Growth Factor B (rhPDGF-BB)-Enhanced Wound Matrix in the Reconstruction of Full-Thickness Head or Neck Defects Following Skin Cancer Excision
- ClinicalTrials.gov ID
- NCT06634030
- Acronym / sponsor ID
- 240597
- Conditions
- Wound Healing, Surgical Wound
- Keywords
- Complex Surgical Defect, Skin Cancer Excision, Platelet-Derived Growth Factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Lynch Regenerative Medicine
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase II clinical trial will evaluate the potential efficacy of rhPDGF-BB-enhanced wound matrix versus wound matrix saturated with normal saline to augment healing of head and neck defects that cannot be healed by primary intention following skin cancer excision. This prospective, double-blinded, single-site study will randomize participants into two arms - intervention and control - comparing the granulation, re-epithelialization, complete healing, and scarring of the wound bed, pain, and quality of life. After recruiting, consenting, and screening, participants will undergo the baseline procedure to place the wound matrix into the wound bed. Randomization will occur immediately before the baseline procedure, and both the PI and participant will be blinded. To achieve balance in treatment allocation, randomization blocks of 4 (2 interventions : 2 controls) will be stratified by anatomical location, scalp versus face/neck, and greatest dimension, < 3cm versus > 3cm, of the surgical defect. Following the baseline procedure, participants will return for their first follow-up visit on day 6 for a clinical examination, suture removal, and wound dressing change, and then again at weeks 4 and 8 for a clinical exam and photographs. Pain and adverse events will be evaluated and documented weekly through the participants' electronic health records, phone call, email survey, or in-person. Participants will submit daily photographs of the wound while performing dressing changes at home starting on day 7 until day 56. These photographs will be taken using a wound imaging application that will be downloaded to a personal mobile device with assistance from the study coordinator. Each patient will also receive a hard copy of instructions for using the application at home. The mobile application can ensure quality photographs and transfer the images to a password-protected cloud-based portal. The photographs will be analyzed by blinded wound experts, retrospectively, to determine the precise day that the wound bed achieved 81-100% granulation. The imaging software will also be used to trace and measure the rate of healing by granulation, re-epithelialization, and wound closure. Under routine care with a wound matrix (no rhPDGF-BB), the average time to granulation is 4-6 weeks in this patient population. Here, we aim to reduce the time to readiness by adding rhPDGF-BB. It is expected that all participants will complete the study which begins at time of signing informed consent and ends at the final study follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline matrix | Placebo comparator | Drug: SalineParticipants receive wound matrix saturated with normal saline. |
| rhPDGF-BB matrix | Experimental | Drug: RhPDGF-BBParticipants receive wound matrix saturated with rhPDGF-BB. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Evidence of current clinical infection as demonstrated by the invasion of bacteria into the healthy viable tissue on the periphery of the wound (colonization of wound bed due to normal flora or environment is not exclusionary)
- Prior radiation therapy at the application site
- Known allergic reactions to porcine tissue, porcine collagen, or yeast-derived products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhPDGF-BB0.3 mg/mL rhPDGF-BB | Drug | rhPDGF-BB matrix |
| SalineNormal saline | Drug | Saline matrix |
Primary outcome
Time-to-Readiness for Skin Graft in Days
Time frame: Daily, starting at day 7 up to day 56 following the baseline procedure
Time to 81-100% granulation of wounds as assessed by expert clinical review of photographs taken daily starting at day 7
14 secondary outcomes
Granulation Rate
Time frame: Daily, starting at day 7 up to day 56 following the baseline procedure
Change in Granulation on a 5-Point Scale
Time frame: Weekly, starting at week 1 up to week 8 following the baseline procedure
Time to re-epithelialization
Time frame: Daily, starting at day 7 up to day 56 following the baseline procedure
Re-epithelialization rate
Time frame: Daily, starting at day 7 up to day 56 following the baseline procedure
Time to complete healing
Time frame: Daily, starting at day 7 up to day 56 following the baseline procedure
Healing rate
Time frame: Daily, starting at day 7 up to day 56 following the baseline procedure
Aesthetics Rating at Week 8
Time frame: Week 8
Scar Scale at Week 8
Time frame: Week 8
Change from Baseline in Pain on an 11-Point Scale
Time frame: From enrollment through week 8
Change from Baseline in Quality of Life
Time frame: From enrollment through week 8
Number of Participants Recruited and Eligible
Time frame: Monthly up to month 15
Number of Participants Randomized Per Month
Time frame: Monthly up to month 15
Proportion of Participants Retained at Week 8
Time frame: Week 8
Weekly Percentage of Completed Daily Photos at Week 8
Time frame: Weekly, week 1 up to week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42145621Clark CR, Blette BS, Guzman RAT, Lempicki MD, Karamitros G, Gergoudis F, Gutama BW, O'Neill DR, Savitz B, Smith J, Shirey-Rice JK, Pulley JM, Lynch SE, McGonigle TW, Thayer WP. Study protocol and statistical analysis plan for a randomized, double-blind, controlled trial evaluating recombinant human platelet-derived growth factor B (rhPDGF) in the reconstruction of complex head or neck defects following skin cancer excision. medRxiv [Preprint]. 2026 May 4:2026.05.01.26352276. doi: 10.64898/2026.05.01.26352276.
- Derived from this study: PubMed 40952157Younan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Self principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RhPDGF-BB and Saline in people with Wound Healing and Surgical Wound, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Readiness for Skin Graft in Days (time frame: Daily, starting at day 7 up to day 56 following the baseline procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06634030, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.