Cellular Versus Acellular Matrix Products for Diabetic Foot Ulcer Treatment: The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE)—A Randomized Clinical Trial
Authors' conclusion
No difference in efficacy was found between SOC, ACM, and CM, suggesting that SOC can reduce the economic burden of diabetic foot ulcer treatment.
Study context
- Population
- Patients aged ≥18 years with a full-thickness nonhealing DFUrandomized
- Participants
- 117 patients
- Comparison
- Cellular matrix vs acellular matrix vs standard of care
- Cellular matrix (CM)n = 41
- Acellular matrix (ACM)n = 48
- Standard of care (SOC)n = 28reference
- Primary endpoint
- Percentage of wounds healed (complete re-epithelialization)
- Follow-up
- 12 weeks
Methodological detailssingle-blinded, three-arm, 21 withdrawals, 7 of whom had reached the first primary end point
- Single-blinded
- Three-arm
- 21 withdrawals, 7 of whom had reached the first primary end point
Primary result
As reported in the abstract
Complete re-epithelialization of the ulcer
P = 0.16 by χ2 test
- Healed overall
- 59%
Further findings
Healed · 28 weeks — between CM and ACM · across CM, ACM and SOC
P = 0.78
Wound recidivism
- No differences between groups
Safety
- No differences in adverse event occurrence between groups
Original publication
Cellular Versus Acellular Matrix Products for Diabetic Foot Ulcer Treatment: The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE)—A Randomized Clinical Trial. Diabetes Care. Published 29 April 2025. doi:10.
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