Innovative wound management of refractory venous ulcers with topical oxygen therapy

Topical oxygen therapy (tOT) is a novel treatment method capable of expediting granulation tissue formation in patients with non-healing lower extremity venous leg ulcers (VLUs). tOT provides cyclic oxygen with compression and is able to be administered at home, unlike chamber-based oxygen therapy. Although previous randomized prospective trials have demonstrated effectiveness of tOT in treating ulcers of diabetic etiology, its ability to promote healing in refractory venous ulcers requires additional exploration. Thus, we investigated preliminary outcomes of tOT administration in treatment-resistant VLUs.

We conducted a single-center retrospective review of treatment outcomes among 31 patients with 32 total extremities with VLUs following longitudinal administration of tOT. All patients received managed Medicaid approval for tOT after each ulcer failed to resolve following multiple alternative therapies, including Unnaboot compression, sclerotherapy, thermal ablation, iliac vein stenting, and debridement. Patient response to tOT was determined by assessing mid-treatment progression of ulcer length and width, in addition to final ulceration status at the conclusion of therapy. Mean treatment length, total ulcer duration, peak ulcer length, and peak ulcer width were determined for each patient and compared between healed and unhealed VLUs.

The average age across all individuals was 73 ± 19 years (range, 27-99 years). Fourteen patients (45%) were male, with a racial breakdown of 18 White (58%), five Hispanic (16%), six Black (19%), and two Asian (6%) patients. Comorbid conditions included hypertension in 31 patients (100%), hyperlipidemia in 15 (48%), and diabetes in 12 (39%). Four patients (13%) demonstrated a former history of smoking, whereas three patients (10%) were currently using tobacco products during the study period. Total duration across all VLUs was 1075 ± 1004 days. The average duration of tOT was 265 ± 233 days, whereas the average pretreatment ulcer duration was 718 ± 842 days. The mean ulcer length was 7.6 ± 6.8 cm, and the mean ulcer width was 5.7 ± 5.0 cm (range, 2-24 cm for both). Following tOT administration, 11 VLUs (34%) healed entirely, nine ulcers (28%) improved but did not completely heal, eight (25%) remained unchanged, and four (13%) worsened despite treatment. The median time to healing among the 11 VLUs that healed completely was 121 days. For ulcers that did not heal, the mean duration of tOT was 333 ± 261 days. No differences were observed in the pretreatment VLU duration (P = .54), maximum length (P = .50), or maximum width (P = .80) of healed vs unhealed VLUs.

Twenty of the 32 refractory VLUs (62.5%) treated with tOT either decreased in size or healed entirely after failing multiple previous therapies. Three of the 11 ulcers (27.3%) that healed completely recurred following topical oxygen therapy.