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A clinical trial of Integra Template for diabetic foot ulcer treatment
Open accessAbstract
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
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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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A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Cell-based products also need multiple reapplications in treating a DFU whereas this study demonstrated that reapplications of IDRT are generally not necessary.”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > DISCUSSION
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p 5 0.001) at sixteen weeks.”
- Also stated in: § Study subjects · plain
“Complete closure of the study ulcer during the treatment phase (16 weeks), as defined by the investigator, was significantly greater in the active group (51%; 79/154) in comparison to the control group (32%; 49/153, p 5 0.001).”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Abstract
plainstates a cause- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § Study subjects · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed.”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The majority of AEs in both groups were mild.”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Study subjects
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p 5 0.012).”
§ A clinical trial of Integra Template for diabetic foot ulcer treatment > Abstract
plainstates an association- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
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In the citing paper
“Although the final follow-up wound area was similar between two treatment groups, the percentage area reduction (PAR) was demonstrated to be significantly increased in several studies [23, 26, 27, 31, 34].”
From Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials (2024) · cites this paper as [23]
Citations
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Nanotechnology-Driven Therapeutic Interventions in Wound Healing: Potential Uses and Applications
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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 & 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
- Semantic Scholar
- d7c51f0598a489f6edfd9a38e932c572e1097785
- 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
- bronze
- doi.org
- 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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