Achieving timely healing of foot ulcers can help avoid complications such as infection and amputation; topical oxygen therapy has shown promise in achieving this. We evaluated the clinical effectiveness of Granulox, a hemoglobin spray device designed to deliver oxygen to the surface of wounds, for the healing of foot ulcers.
We conducted a single-center, prospective, randomized controlled trial comparing standard of care (once-weekly podiatric medical clinic visits) versus standard care plus adjunct Granulox therapy twice weekly in adults with foot ulcers. After a 2-week screening phase, patients in whom the index wound had healed by less than 50% were randomized 1:1. Outcome measures were collated during the trial phase at 6 and 12 weeks.
Of 79 patients enrolled, 38 were randomized. After 12 weeks, the median percentage wound size reduction compared with the size of the ulcer at the start of the trial phase was 100% for the control arm and 48% for the Granulox arm (P = .21, Mann-Whitney U test). In the former, eight of 14 foot ulcers had healed; in the latter, four of 15 (P = .14, Fisher exact test). In the control arm, two amputations and one withdrawal occurred, whereas in the Granulox arm, one unrelated death and five withdrawals were recorded.
We could not replicate the favorable healing associated with use of Granulox as published by others. Differences in wound chronicity and frequency of Granulox application might have influenced differences in study results. Granulox might perform best when used as an adjunct for treatment of chronic wounds at least 8 weeks old.
Background: Point-of-care testing for infection might help podiatric physicians optimize management of diabetic foot ulcers (DFUs). Glycologic’s proprietary GLYWD product has been developed to detect changes in a patient’s immunologic/inflammatory response related to wound infection. We evaluated how bacterial presence in DFUs relates to GLYWD test outcome.
Methods: This was a single-organization, prospective, controlled cohort study of clinical opinion versus GLYWD test result for DFU infection status and the appraisal of bacterial presence in the wounds and semiquantitative microbiology swab at weeks 0, 3, 6, 12, and 18. Spearman correlation, backward elimination linear regression, and principal components analysis were applied to determine which variables, including degree of bacterial load, are associated with a positive clinical opinion or GLYWD result for DFU infection.
Results: Forty-eight patients were enrolled, and 142 complete wound appraisals were conducted; a consensus outcome between clinical opinion and GLYWD result was achieved in most (n = 122, 86%). Clinical opinion significantly correlated with a higher bacterial load (Spearman rho = 0.38; P < .01), whereas GLYWD did not (rho = –0.010; P = .91). This observation was corroborated with logistic regression analysis, in which a previous observation of both clinical opinion and GLYWD associating with wound purulence and erythema was also confirmed.
Conclusions: Podiatric physicians are guided by hallmark signs of DFU infection, such as erythema and purulence; furthermore, we found that clinical opinion of infection correlates with increased bacterial load. GLYWD test results match clinical opinion in most cases, although the results obtained with this point-of-care method suggest that the degree of bacterial presence might not necessarily mean a higher chance of inducing an immunologic/inflammatory host response to said bacteria.