In a large retrospective study of Medicare patients with non–pressure injury chronic wounds, a defined series of cellular and/or tissue-based product (CTP) applications led to significant wound area reduction and closure across diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), surgical wounds, trauma wounds, and other chronic wounds. The findings support the effectiveness of CTP therapy in real-world outpatient and home-based care settings.

Key Takeaways

·      CTP applications significantly reduced wound size across all chronic wound types, including DFUs, VLUs, surgical, trauma, and other wounds.

·      Over 50% of wounds achieved full closure within 10 CTP applications, with healing often occurring after just 4 to 6 treatments.

·      This real-world study supports the use of CTP therapy in outpatient, home, and long-term care settings, improving access to effective wound care for older Medicare populations.

In a large retrospective cohort study of Medicare patients treated in outpatient settings, a series of cellular and/or tissue-based product (CTP) applications was associated with significant wound area reduction across all evaluated non–pressure injury chronic wound types, including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), surgical wounds, trauma wounds, and other chronic wounds. All wound categories demonstrated statistically significant decreases in mean wound area from the first to the final CTP application, with large effect sizes, and approximately half of all wounds achieved closure within a series of 10 or fewer applications.¹ 

What was the study design and patient population?

This investigation was a retrospective, derivative cohort study using electronic health record data from a multicenter private wound care practice in rural Louisiana and Mississippi. The analysis included Medicare-insured patients who received CTP applications between January 2018 and December 2023 in private clinics, nursing homes, or home settings.¹

Key design features included¹:

• Inclusion of chronic, non–pressure injury wounds present for at least 4 weeks
• Mandatory ≥30 days of standard of care before CTP initiation
• Eligibility limited to wounds ≤25 cm² at baseline
• A defined CTP series of ≤10 applications completed within 16 weeks

A total of 446 wounds from 377 patients met inclusion criteria. Wound etiologies comprised DFUs (n = 123), VLUs (n = 134), surgical wounds (n = 62), trauma wounds (n = 51), and other chronic wounds (n = 76). Most patients were aged ≥65 years, and common comorbidities included diabetes mellitus and hypertension.¹ 

How did wound area change with CTP treatment?

Across all wound types, mean wound area decreased progressively with each successive CTP application. Paired samples analyses comparing initial wound area with final wound area showed statistically significant reductions for every etiology (all P < .001).¹

Reported mean wound area changes included¹:

• Surgical wounds: from 10.2 cm² to 1.96 cm² (Cohen d = 1.38)
• Trauma wounds: from 7.19 cm² to 0.88 cm² (Cohen d = 0.96)
• Other chronic wounds: from 7.21 cm² to 0.94 cm² (Cohen d = 1.0)

These findings were consistent with previously published DFU and VLU results using the same methodology. According to the authors, large effect sizes across all wound categories indicated clinically meaningful reductions rather than small statistical changes.¹ 

What proportion of wounds healed, and how many applications were required?

Overall, 227 of 446 wounds (50.9%) achieved closure within a maximum of 10 CTP applications. Healing rates varied by etiology¹:

• Trauma wounds: 62.75% healed
• Other chronic wounds: 60.53% healed
• VLUs: 53.73% healed
• Surgical wounds: 43.55% healed
• DFUs: 40.65% healed

Among healed wounds, closure typically occurred after 4 to 6 applications. The mean number of applications required for healed wounds ranged from 4.38 for trauma wounds to 6.06 for DFUs. Both monotherapy and combination CTP strategies were used, with most healed wounds receiving monotherapy during the treatment series.¹ 

What are the clinical implications for practice?

According to the study’s authors, findings suggest that incorporating CTP applications alongside standard wound care may substantially reduce wound area and support closure in a broad range of chronic wound etiologies beyond DFUs and VLUs. The consistency of wound area reduction across etiologies indicates that CTP therapy may address shared biological barriers to healing in chronic wounds.¹

Importantly, the study reflects real-world practice in non-hospital outpatient environments, including home-based care, which may enhance treatment accessibility for certain patient populations. The defined application limit of 10 treatments within 16 weeks also aligns with current Medicare coverage determinations, increasing the relevance of the results for clinical decision-making.¹             

What limitations should clinicians consider?

The authors identified several important limitations¹:

• Retrospective design without a control group
• Restriction to Medicare patients in non-hospital settings, limiting generalizability
• Exclusion of wounds >25 cm² and patients with certain systemic conditions
• Inability to determine comparative effectiveness among individual CTP products

Additionally, healing time was not uniformly captured, and outcomes beyond 16 weeks were not assessed. These factors limit causal inference and preclude direct comparison with standard care alone.¹ 

Conclusion

In this real-world retrospective analysis, a defined series of CTP applications was associated with significant wound area reduction and meaningful healing rates across multiple non–pressure injury chronic wound types in Medicare patients. The study demonstrates that surgical, trauma, and other chronic wounds demonstrated reductions comparable to those historically observed in DFUs and VLUs, supporting broader clinical use of CTP therapy within established coverage parameters.¹

Reference:

Carpenter S, Ferguson A, Bahadur D, Estapa A, Bahm J, Burst S. Efficacy of cellular and/or tissue-based product applications on all non–pressure injury chronic wound types in a Medicare private practice model. Wounds. 2025;37(8):292-304. doi:10.25270/wnds/25005