Topical hyperbaric oxygen and low-energy laser for the treatment of chronic ulcers

Background

Diabetic foot ulcers (DFU) and chronic venous ulcers (CVU) are persistent cutaneous lesions that are difficult to treat and heal. Topical hyperbaric oxygen (THO) and low-energy laser (LEL) are therapies that have been employed separately for ulcer treatment, but their concomitant use has not been investigated.

Methods

In this unblinded, open-label non-randomized trial, we treated 374 consecutive patients with treatment-refractory chronic ulcers (218 patients with DFU and 156 individuals with CVU) with a combination of THO and LEL. THO was administered by pumping 100% oxygen into a disposable, sealed polyethylene chamber for 2 h, two to three times weekly. LEL was administered concurrently using a helium–neon laser at 4 J/cm² for 20 min.

Results

Complete ulcer closure was obtained in 78% of patients in each group (170 patients with DFU and 127 patients with CVU). Treatment failure resulting in amputation in DFU was seen in 48 patients (22%); non-closure of ulcers within 18 months in individuals with CVU was seen in 29 (22%). The length of therapy was also similar in the two groups (3.7 ± 3 versus 4.1 ± 3 months in DFU and CVU cohorts, respectively). However, the number of treatments required to affect healing was greater in the CVU group than among the DFU patients (40 ± 25 versus 31.4 ± 20 treatments).

Conclusion

THO and LEL therapies are safe, effective, simple and inexpensive therapies for DFU and CVU. Confirmation must await the performance of double-blind, randomized, controlled trials currently under way.

Introduction

Diabetic foot ulcers (DFU) and chronic venous ulcers (CVU) are cutaneous lesions that are difficult to treat and heal. Conventional therapies, including local treatment/debridement and antibiotics, are frequently ineffective. Even when successful, these treatments result in wound healing that occurs slowly and with a great deal of pain and disability.

Topical hyperbaric oxygen (THO) therapy is a technique that was used to treat diabetic foot ulcers in a few uncontrolled clinical trials in the 1960s and 1970s [1], [2], [3]. However, this therapy was almost completely neglected in the western world, especially after Leslie et al. published their unfavorable experience with THO in patients with DFU [4].

Despite this unfavorable report, interest in THO continued among a few groups [5], [6], [7] and, recently, interest in this modality has increased. For example, Sen et al. published their treatment experience with THO and the possible role of topical oxygen in the mechanism of wound healing [8], [9]. In addition, THO administered by inflatable “oxygen boots” was approved by the Food and Drug Administration (FDA) for the treatment of DFU and it is currently used by many clinics around the U.S.

The technology of low-energy laser (LEL) was introduced into clinical medicine more than three decades ago but had received little attention [10]. LEL has a stimulating effect on cell mitosis [11], keratinocyte migration [12], proliferation [13] and cytokine production [14], and it may lead to increased dermal angiogenesis [15]. Animal experiments have suggested an enhancing effect of LEL on wound healing and this was supported by a few preliminary clinical studies [16], [17], [18], [19], [20], [21].

Investigations using both THO and LEL have not been previously reported, yet a synergistic effect is possible and our preliminary results were encouraging. In this observational prospective study, we report our experience with a combination of these modalities in the treatment of patients with chronic ulcers for whom conventional treatment failed.