Hyaluronic acid dressing (Healoderm) in the treatment of diabetic foot ulcer

A prospective, randomized, placebo-controlled, single-center study

Moses Lee, Seung Hwan Han, Woo Jin Choi, Kwang Ho Chung, jinwoo lee

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Fast and complete healing of a diabetic foot ulcer (DFU) is challenging due to the hostile wound healing environment of the diabetic patients. As a part of a multimodal treatment approach, advanced dressing material using hyaluronic acid (HA) has been found to be effective. However, previous studies have used HA with additional biologics, which interferes in determining the true clinical effect of HA in DFU. To examine the sole effectiveness of HA in DFU treatment, a prospective, randomized, placebo-controlled, single-center study was conducted using an HA dressing without additional substances. Thus, 34 patients who met the inclusion criteria were randomized into two groups (the study group: HA dressing material; the control group: conventional dressing material). During the 12-week study period, complete ulcer healing rate was evaluated as a primary endpoint. Additionally, healing velocity and the mean duration for achieving a 50% ulcer size reduction was compared between the two groups as a secondary endpoint. At the end of the study, the study group presented a significantly higher complete healing rate as compared to that in the control group [84.6% (11/13), 41.6% (5/12), respectively, P = 0.041]. Additionally, faster ulcer healing velocity and shorter mean duration for achieving a 50% ulcer size reduction were observed in the study group (P = 0.022 and 0.004, respectively). The Kaplan-Meier survival analysis for the median time for 50% ulcer healing rate also showed a significantly shorter duration in the study group (21 days vs. 39 days, P = 0.0127). Finally, there were no adverse events related to the dressing materials used in the study. As a major component of the extracellular matrix, this study supports the safety and efficacy of a pure HA dressing without additional substances in treating DFU.

Original languageEnglish
Pages (from-to)581-588
Number of pages8
JournalWound Repair and Regeneration
Volume24
Issue number3
DOIs
Publication statusPublished - 2016 May 1

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Diabetic Foot
Hyaluronic Acid
Bandages
Placebos
Ulcer
Therapeutics
Combined Modality Therapy
Control Groups
Kaplan-Meier Estimate
Survival Analysis
Biological Products
Wound Healing
Extracellular Matrix
Safety

All Science Journal Classification (ASJC) codes

  • Surgery
  • Dermatology

Cite this

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title = "Hyaluronic acid dressing (Healoderm) in the treatment of diabetic foot ulcer: A prospective, randomized, placebo-controlled, single-center study",
abstract = "Fast and complete healing of a diabetic foot ulcer (DFU) is challenging due to the hostile wound healing environment of the diabetic patients. As a part of a multimodal treatment approach, advanced dressing material using hyaluronic acid (HA) has been found to be effective. However, previous studies have used HA with additional biologics, which interferes in determining the true clinical effect of HA in DFU. To examine the sole effectiveness of HA in DFU treatment, a prospective, randomized, placebo-controlled, single-center study was conducted using an HA dressing without additional substances. Thus, 34 patients who met the inclusion criteria were randomized into two groups (the study group: HA dressing material; the control group: conventional dressing material). During the 12-week study period, complete ulcer healing rate was evaluated as a primary endpoint. Additionally, healing velocity and the mean duration for achieving a 50{\%} ulcer size reduction was compared between the two groups as a secondary endpoint. At the end of the study, the study group presented a significantly higher complete healing rate as compared to that in the control group [84.6{\%} (11/13), 41.6{\%} (5/12), respectively, P = 0.041]. Additionally, faster ulcer healing velocity and shorter mean duration for achieving a 50{\%} ulcer size reduction were observed in the study group (P = 0.022 and 0.004, respectively). The Kaplan-Meier survival analysis for the median time for 50{\%} ulcer healing rate also showed a significantly shorter duration in the study group (21 days vs. 39 days, P = 0.0127). Finally, there were no adverse events related to the dressing materials used in the study. As a major component of the extracellular matrix, this study supports the safety and efficacy of a pure HA dressing without additional substances in treating DFU.",
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Hyaluronic acid dressing (Healoderm) in the treatment of diabetic foot ulcer : A prospective, randomized, placebo-controlled, single-center study. / Lee, Moses; Han, Seung Hwan; Choi, Woo Jin; Chung, Kwang Ho; lee, jinwoo.

In: Wound Repair and Regeneration, Vol. 24, No. 3, 01.05.2016, p. 581-588.

Research output: Contribution to journalArticle

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