Dermagraft's clinical proof in healing DFUs is extensive and reliable. Time and again, it healed more DFUs faster—even in patients who were not optimally offloaded and in wounds on the plantar surface of the foot.1-7

Reliable = Randomized Controlled Trial (RCT) Data 
PLUS Real-world Observational Studies

Reliable data Equals:


  • Strongest method for proving efficacy and safety
  • Required to obtain FDA approval

Real-world observational studies1,2

  • Provide evidence of health benefit in real-world use
  • Demonstrate effectiveness in patients with significant comorbidities
Dermagraft's evidence is
extensive and reliable

RCT for FDA approval3,4

 DFUs (N=245)

Real-world observational studies5-7

 3 in DFUs (N=1952)

RCT=randomized controlled trial; Ns for RCTs=number of patients; Ns for real-world observational studies=number of wounds.


Dermagraft healed significantly more patients faster—
even in tough-to-treat wounds.3,4

Percent of patients with 
complete healing by 12 weeks

  • In a phase 3 multicenter, prospective, randomized, controlled trial, Dermagraft plus conventional therapy resulted in significantly more patients with DFUs greater than 6-weeks duration achieving complete wound closure by week 12 vs conventional therapy alone (30% vs 18%; P=0.023)
  • By week 12, the median percent wound closure for the Dermagraft group was 91% compared with 78% for the control group (P=0.044)
Patients were
ambulatory for


wounds were on
the plantar surface

8 hours

per day

All of the wounds were located on the plantar aspect of the foot and patients were allowed to be ambulatory.4

Patients used extra-depth diabetic footwear with custom inserts or healing sandals.

From daily patient diaries, patients in both the Dermagraft and control groups were on their feet an average of 8 hours a day during the study.

As part of the evaluation of clinical trial adverse events, Dermagraft was shown 
to reduce complications, including amputations and bone resections.8

Frequency of patients experiencing
a study ulcer-related amputation or 
bone resection at 12 weeks*


fewer amputations
and bone resections

*This study was not designed to determine the incidence 
of amputations and resections. Data were acquired through 
evaluation of clinical trial adverse events.


The trend is REAL, Dermagraft closed more wounds faster in three real-world observational studies*

Effectiveness is the extent to which an intervention produces an overall health benefit in routine clinical practice (real-world situations). Effectiveness studies do not establish efficacy or comparative superiority.

For the Dermagraft vs. EpiFix study, estimated frequency of wound closure is from a Cox regression model with terms for treatment, baseline wound area, baseline wound duration, baseline wound depth, and wound location. All 2014 data were included in the analysis. EpiFix is a registered trademark of MiMedx Group, Inc.

For the Dermagraft vs. Grafix study, the primary analysis comparing incidence of and median time to complete wound closure were determined by Kaplan-Meier analysis with a two-tailed log-rank test. Averages for the treatment group were applied to the missing data. The hazard ratio along with its 95% confidence interval and P-value were based on a Cox proportional hazards regression model with terms for treatment group and baseline wound area as a continuous variable. Data from July 2013 through July 2018 were included in the analysis. Grafix is a registered trademark of Osiris Therapeutics, Inc.

For the Dermagraft vs. PriMatrix study, the primary analyses comparing frequency of and median time to wound closure were determined by Cox proportional hazards analysis with terms for treatment, baseline wound area, baseline wound duration, baseline wound depth, wound location, and patient age at first treatment. All 2014 data were included in the analysis. PriMatrix is a registered trademark of Integra LifeSciences Corporation.

For all analyses, wound closure defined as an ulcer achieving an area between 0 and 0.25 cm2.

*Based on a retrospective analysis of data obtained from a large wound care–specific electronic medical records (EMR) database. WoundExpert® (Net Health), utilized by ~90% of wound care facilities across the US. De-identified patient data released to Organogenesis were consistent with the terms and conditions of Net Health's participating client contracts and the requirements of HIPAA. Net Health was not involved in any way in the analyses, interpretation, or reporting of the data.


The cost of treating DFUs and DFU complications is high.


in associated costs per year9


of diabetes–related
end in death10,11

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Please refer to the Dermagraft Directions for Use for complete prescribing information.


  1. Carter MJ, et al. Adv Skin Wound Care. 2009;22(7):316-324.
  2. Horn S. JAMA. 2006;296(22):2731-2732.
  3. Dermagraft Directions for Use. Organogenesis Inc; 2015.
  4. Marston WA, et al. Diabetes Care. 2003;26(6):1701-1705.
  5. Kraus I, et al. Wounds. 2017;29(5):125-132.
  6. Sabolinski ML, et al. J Comp Eff Res. 2019;8(14):1229-1238.
  7. Fitzgerald R, et al. Wound Manag Prev. 2019;65(9):26-34. doi: 10.25270/wmp.2019.9.2634.
  8. Frykberg R, et al. Adv Skin Wound Care. 2015;28(1):17-20.
  9. Barshes NR, et al. Diabet Foot Ankle. 2013;4. doi:10.3402/dfa.v4i0.21847.
  10. Armstrong DG, et al. Int Wound J. 2007;4(4):286-287.
  11. Moulik PK, et al. Diabetes Care. 2003;26:491-494.
  12. Rice JB, et al. J Med Econ. 2015;19(8):586-595.