The incidence of lower-extremity amputation and bone resection in diabetic foot ulcer patients treated with a human fibroblast-derived dermal substitute

Adv Skin Wound Care. 2015 Jan;28(1):17-20. doi: 10.1097/01.ASW.0000456630.12766.e9.


Objective: Diabetic foot ulcers (DFUs) are frequently recalcitrant and at risk for infection, which may lead to lower-extremity amputation or bone resection. Reporting the incidence of amputations/bone resections may shed light on the relationship of ulcer healing to serious complications. This study aimed to evaluate the incidence of amputations/bone resections in a randomized controlled trial comparing human fibroblast-derived dermal substitute plus conventional care with conventional care alone for the treatment of DFUs.

Design: Ulcer-related amputation/bone resection data were extracted from data on all adverse events reported for the intent-to-treat population (N = 314), and amputations were categorized by type: below the knee, Syme, Chopart, transmetatarsal, ray, toe, or partial toe. Data were analyzed retrospectively for the incidence of amputation/bone resection by treatment.

Setting: Randomized controlled trial.

Patients: Patients with full-thickness DFUs greater than 6 weeks' duration.

Interventions: Standard wound care plus human fibroblast-derived dermal substitute versus standard wound care alone.

Main results: The incidence of amputation/bone resection in the study was 8.9% (28/314) overall, 5.5% (9/163) for patients receiving human fibroblast-derived dermal substitute, and 12.6% (19/151) for patients receiving conventional care (P = .031). Of the 28 cases of amputation/bone resection, 27 were preceded by ulcer-related infection.

Conclusion: There were significantly fewer amputations/bone resections in patients who received human fibroblast-derived dermal substitute versus conventional care, likely related to the lower incidence of infection adverse events observed in the human fibroblast-derived dermal substitute treatment group.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amputation / statistics & numerical data*
  • Coated Materials, Biocompatible*
  • Diabetic Foot / surgery*
  • Female
  • Fibroblasts
  • Humans
  • Male
  • Retrospective Studies
  • Skin, Artificial*


  • Coated Materials, Biocompatible
  • TransCyte