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Cited by 291Diabetic Foot Ulcer Assessment and ManagementWound Healing and TreatmentsTissue Engineering and Regenerative Medicine

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index; none of the 38 sources its claims cite is checked for support yet.

A clinical trial of Integra Template for diabetic foot ulcer treatment

Open access

Abstract

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty‐two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14‐day run‐in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run‐in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects ( p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.

Overview

CoChat Summary

TL;DR

In the FOUNDER multicenter randomized trial, Integra Dermal Regeneration Template (IDRT) significantly increased complete closure of chronic diabetic foot ulcers compared with standard of care. IDRT also reduced time to closure and improved some quality-of-life measures, with fewer severe adverse events.

Key findings

  • Complete DFU closure during the 16-week treatment phase was 51% (79/154) with IDRT vs 32% (49/153) with control (p = 0.001); by blinded computerized planimetry, closure was 50% vs 31% (p = 0.001).
  • Median time to complete closure among healed wounds was 43 days for IDRT vs 78 days for control; wound size reduction was 7.2% per week vs 4.8% per week (p = 0.012).
  • At 12 weeks, complete closure was 45% (70/154) with IDRT vs 20% (31/153) with control (p < 0.001), with an odds ratio of 3.3 (95% CI 2.0, 5.4).
  • Severe adverse events occurred in 15.6% of IDRT subjects vs 26.8% of control subjects (p = 0.016); quality-of-life improvements were significant for Physical Functioning (p = 0.047) and Bodily Pain (p = 0.033).

Methods

  • Multicenter, randomized, controlled, parallel-group trial under an Investigational Device Exemption at 32 sites; 307 subjects with nonhealing DFUs were randomized 1:1 to IDRT (n = 154) or control saline gel standard of care (n = 153) after a 14-day run-in in which only ulcers with less than 30% reepithelialization were randomized.
  • Treatment phase lasted up to 16 weeks or until confirmed complete wound closure, followed by a 12-week follow-up; the primary endpoint was investigator-assessed complete closure during the treatment phase, with blinded central computerized planimetry as a secondary assessment.
  • Efficacy analyses used the intent-to-treat cohort; primary outcome used logistic regression adjusted for baseline ulcer size strata, with secondary outcomes analyzed by Cox regression, linear mixed-effects models, and closed testing to maintain type I error at 0.05.

Limitations

  • The paper states that the study was not double-blinded, a limitation it notes applies to this and other DFU studies involving cellular and/or tissue-based products; it reports that this bias was addressed by third-party blinded computerized planimetry.
  • The paper states that strict inclusion/exclusion criteria could affect generalizability, though it argues this was minimized by enrolling from 32 academic and private practice sites across the United States.
  • Evident from the text: the study was sponsored and funded by Integra LifeSciences Corporation, and multiple authors report grants, personal fees, or nonfinancial support from Integra, which is not framed by the authors as a limitation.

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Integrity signals

Registry

Crossref · 10.1111/wrr.12357

Cites

33 of 33 references verified0 citation errors · 0 not checkable

Statistics

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Claims the paper makes

0 Valid · 0 Not valid · 19 Not checked · 53 Own results and interpretations

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Citations

Cites

Show all 33 references

Research works printed but not linked: 3

  1. Boulton A, 2005, Diabetic foot and ulceration: epidemiology and pathophysiology
  2. Gibson D, 2009, MMPs made easy, Wound Int, 1, 1
  3. Gethin G, 2007, Wound measurement: the contribution to practice, EWMA J., 7, 26

Cited by

Items 201–290 of 290

Metadata

Authors
Driver, V. R., Lavery, L. A., Reyzelman, A. M., Dutra, T. G., Dove, C. R., Kotsis, S. V., Kim, H. M., & Chung, K. C.
Affiliations
  • Brown University (US)
  • The University of Texas Southwestern Medical Center (US)
  • University of California, San Francisco (US)
  • Samuel Merritt University (US)
  • Advanced Foot &amp; Ankle Center Las Vegas Nevada
  • University of Michigan (US)
Corresponding author
Driver, Vickie R.
Venue
Wound Repair and Regeneration
Publisher
Wiley
Published
2015-10-19
Volume
23
Issue
6
Pages
891-900
ISSN
  • 1067-1927 (ISSN-L)
  • 1524-475X
OpenAlex
W2159363192
Cited by
291
References
33
Citations by year
2026: 21 · 2025: 24 · 2024: 39 · 2023: 31 · 2022: 31 · 2021: 15 · 2020: 30 · 2019: 20 · 2018: 31 · 2017: 40 · 2016: 7 · 2015: 1
FWCI
17.38
Type
journal article
Language
en
Open access
Locations
  • Wound Repair and Regeneration (publishedVersion)
  • PubMed (publishedVersion)
Funders
Integra LifeSciences Corporation
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
  • Health Sciences › Medicine › Surgery › Wound Healing and Treatments
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
Keywords
diabetic foot ulcer, Integra dermal regeneration template, skin substitutes, wound healing, re-epithelialization, wound closure, diabetes mellitus, quality of life, adverse events
MeSH terms
Chondroitin Sulfates, Collagen, Follow-Up Studies, Humans, Middle Aged, Quality of Life, Regeneration, United States, Wound Healing, Treatment Outcome, Practice Guidelines as Topic, Diabetic Foot, Re-Epithelialization

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Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.