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A Pragmatic, Single-Center, Prospective, Randomized Controlled Trial of Adjunct Hemoglobin-Mediated Granulox Topical Oxygen Therapy Twice Weekly for Foot Ulcers
Results of the Hemoglobin Application to Wounds Study
Background
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.
Methods
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.
Results
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.
Conclusions
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.
Over 90% of the diabetic neurotrophic ulcers treated with the felted foam technique at the Cleveland Foot Clinic have completely healed. The average healing time for plantar ulcers has been approximately 8 weeks. After the ulcerations have healed, molded shoes or orthopedic shoes with Plastazote inserts are prescribed. The felted foam technique is simple to perform in an office setting and can be used by both the novice and the experienced practitioner.
The authors illustrated a chronic bilateral plantar foot ulcer of several years' duration that was resistant to all forms of conventional therapy, yet was resolved after 13 1/2 weeks of maggot therapy. The contralateral foot ulcer showed no improvement during the same period, despite continual inpatient conventional dressing changes. At a time when medical cost containment is a critical issue, maggot therapy may resurge as a viable alternative in treating nonhealing wounds.
Background: The removal of necrotic tissue from chronic wounds is required for wound healing to occur. Hydrodebridement (jet lavage) and superoxidized aqueous solution have been independently used for debriding wounds. We sought to investigate the use of superoxidized aqueous solution with a jet lavage system.
Methods: Twenty patients with diabetic foot ulcers were randomly assigned in a 1:1 ratio to receive jet lavage debridement with either superoxidized aqueous solution or standard saline weekly.
Results: There was no significant difference between the two treatments in the reduction of bacterial load or wound size in 4 weeks. No adverse reactions were reported for either treatment.
Conclusions: The use of superoxidized aqueous solution for jet lavage debridement seemed to be as safe and effective as saline. Future investigations should concentrate on whether superoxidized aqueous solution may reduce the bacterial air contamination associated with hydrodebridement. (J Am Podiatr Med Assoc 101(2): 124–126, 2011)
The evaluation of ulcer size is normally limited to measuring length, width, and depth, and comparing those figures to previously obtained values. These comparisons are grossly inaccurate, and a more representative technique can be used by treating the ulceration as a three-dimensional object. The author proposes several mathematical formulae that are easily computed on a hand-held calculator. The formulae use the measurements of length, width, and depth, and translate those dimensions into surface area and volume.
Background: Exercise has not been studied extensively in persons with active neuropathic diabetic foot wounds, primarily because a device does not exist that allows patients to exercise while sufficiently off-loading pressure at the ulcer site. The purpose of this project was to demonstrate a device that reduces cycling plantar forefoot pressure.
Methods: Ten healthy participants rode a recumbent bicycle under three cycling conditions. While the left foot interaction remained constant with a standard gym shoe and pedal, the right foot was exposed to a control condition with standard gym shoe and pedal, gym shoe and specialized cleat, and gym shoe with an off-loading insole and specialized cleat. Pressure and contact area of the plantar aspect of the feet were recorded for a 10-sec interval once during each minute of each condition’s 7-min trial.
Results: The off-loading insole and specialized cleat condition yielded significantly lower (P < .01) peak pressure, contact area, and pressure–time integral values in the forefoot than the specialized cleat condition with gym shoe, which yielded significantly lower values (P < .01) than the standard gym shoe and pedal.
Conclusion: Modifications to footwear may alter plantar forefoot pressures, contact area, and pressure–time integrals while cycling. The CLEAR Cleat could play a significant role in the facilitation of fitness in patients with (or at high risk for) neuropathic wounds. (J Am Podiatr Med Assoc 98(4): 261–267, 2008)
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.
