Haemoglobin spray (Granulox) for diabetic foot ulcers

NewsBot · Nov 7, 2014

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Pilot study: haemoglobin spray in the treatment of chronic diabetic foot ulcers
Paul Chadwick
Wound UK 10(4) 2014

Wounds cannot heal without oxygen. In fact, healing wounds demand more oxygen than healthy tissue — yet chronic wounds are often at least partly due to vascular insufficiency. A novel spray aims to make use of haemogolobin, the transport molecule for oxygen in the bloodstream, to bind atmospheric oxygen and deliver it to the hypoxic wound bed. The product, Granulox® (Infirst Healthcare), may be of particular interest in patients with impaired levels of tissue perfusion/oxygenation, which may be impeding wound healing.
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NewsBot · Aug 7, 2015

Press Release:
New study unveils promising results for Granulox in treating diabetic foot ulcers

Innovative oxygen therapy, Granulox?, is hailed as an effective, safe and easy-to-use treatment, with the potential to revolutionise wound care, according to data presented at the recent European Wound Management Association (EWMA) conference, and published in the British Journal of Nursing.

The comprehensive study – the first of its kind in the UK – was conducted by South Tees NHS Hospitals Foundation Trust and treated 20 patients with non-healing diabetic foot ulcers that were present for 12 weeks or more, with Granulox?. After just four weeks, all trial patients reported a reduction in wound surface area, elimination of slough and an improvement in exudate levels.

A quarter of patients reported a 100% reduction in wound area. The average wound size reduction was 62.3%, and even wounds which had been present for 12 months or more reduced by an average of 24% within the four weeks.1

All patients with a previous wound bed slough between 10%-100% were slough-free, with no debridement required during the treatment with Granulox?. In addition, significant reduction in exudate levels across all patients: a 29% reduction in wounds with mild exudate (2 out of 7 patients), a 86% reduction in moderate exuding wounds (6 out of 7 patients) and a complete resolution (100%) of all six patients with severe exuding wounds. These results demonstrate the transformative impact of Granulox? in patients with previously non-healing wounds.1

Both the patient and clinician experience of Granulox? was positive, with the treatment’s easy-to-use spray functionality hailed as a key product benefit. Sharon D. Bateman, study author and specialist tissue viability nurse remarks: “Diabetic foot ulcers have a significant impact on a patient’s quality of life and place patients at higher risk for lower limb amputations. The management of DFU patients can place a significant burden on NHS resources. Aside from the clinical benefits seen in the trial, 75% of patients were able to apply Granulox? independently, making the prospect of patients managing their DFU independently or with the help of their healthcare team a distinct reality.”1

Manfred Scheske, CEO, infirst Healthcare comments: “As an area of huge unmet need, the latest data demonstrating that Granulox? promotes rapid and complete wound closure should revolutionise the way clinicians approach the management of foot ulcers in patients with diabetes. This latest trial adds to the evidence base for Granulox? as part of a gold standard wound-care regime.”

Additional study details

The trial included 20 adult patients with diabetic foot ulcers located beneath the ankle – the most common anatomical site for DFUs to occur. Of the 20 patients in the study, 7 (35%) patients suffered from type 1 diabetes with the remaining 13 patients, (65%) with type 2 diabetes. Study participants were classified as scoring 2 on the Site, Ischemia, Neuropathy, Bacterial Infection, Area and Depth (SINBAD) scale, which assess the severity of foot ulcers and the risk factors that may inhibit healing. Patients with a SINBAD score of 3 or higher were excluded from the trial, alongside pregnant participants, patients suffering from infected ulcers or who were receiving antibiotic or corticosteroid therapy.
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NewsBot · Mar 29, 2016

Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs.
Haycocks Set al
Br J Nurs. 2016 Mar 24;25(6):S54-S62.

AIM:
The aim of this multi-centre observational evaluation was to assess the percentage reduction in wound area of non-healing diabetic foot ulcers (DFUs), treated with Granulox haemoglobin spray over a 4-week period. Secondary outcome parameters-for example, adverse events, patient acceptability and ease of use-were also recorded.
METHOD:
After a run-in-period (2 weeks for existing patients and 4 weeks for new patients) to determine if the wounds were non-healing despite receiving local best practice, patients whose foot ulcers had decreased in size by < 20% were then entered into the evaluation. A sample of 17 patients (4 females and 13 males), comprising 4 with type 1 and 13 with type 2 diabetes, with a total of 20 DFUs, met the inclusion criteria. These data were collected from six sites across the UK.
RESULTS:
There was an overall positive reduction in size in 15 of the wounds, equating to a mean reduction of 53.8% (standard deviation (SD): 26.6; range: 11.9-100%). One participant, with two ulcers, had to be withdrawn due to infection. All clinicians and participants found the product easy to use.
CONCLUSION:
The addition of a topical oxygenation therapy in this cohort of non-healing DFUs showed reduction in wound surface area and progression to healing. The product was also found to be acceptable and very easy to use by both participants and clinicians.
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NewsBot · Jun 28, 2016

Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs: clinical outcomes at 12 weeks.
Dawn Hunt S, Haycocks S, McCardle J, Guttormsen K
Br J Nurs. 2016 Jun 23;25(12):S59-64

A recent multi-centre observational evaluation investigated the effect of a topical haemoglobin spray (Granulox, Infirst), used as an adjunct to standard care, on wound size reduction in 17 patients (4 females/13 males) with 20 chronic diabetic foot ulcers (DFUs) over a 4-week period. In 14 of the 18 wounds that completed the evaluation (one patient dropped out due to an infection) there was a mean reduction of 53.8% (range: 11.9-100%). The product was acceptable to both patients and clinicians, who all found it easy to use. This article describes the outcomes for the remaining 13 patients (with 15 wounds) who continued using the spray after the 4-week evaluation ended. (Data are not available for two patients and the one patient who healed during the 4-week evaluation.) By 12 weeks, three wounds (20%) had healed, eight (53%) were progressing towards healing, three (20%) increased in size and one (7%) was slow healing.
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NewsBot · Nov 7, 2016

CLINICAL EFFECTIVENESS OF HEMOGLOBIN SPRAY (GRANULOX®) AS ADJUNCTIVE THERAPY IN THE TREATMENT OF CHRONIC DIABETIC FOOT ULCERS
Sharon D. Hunt, RGN, Dip, BSc Hons, MA and Fredrik Elg, PhLic, MSSc, MBA, BA, Dip Eng
Diabetic Foot & Ankle 2016, 7: 33101

Introduction: Hemoglobin spray (Granulox®) comprises purified hemoglobin and is a novel approach for increasing oxygen availability in the wound bed in diabetic foot ulcer patients. Its mode of action is to bind oxygen from the atmosphere and diffuse it into the wound bed to accelerate wound healing in slow-healing wounds.

Patients and methods: Wound healing outcomes, that is, wound size, pain, percentage of slough, and exudate levels, were compared retrospectively to a similar cohort of patients treated over the same period the previous year. The same inclusion and exclusion criteria applied to both groups.

Results: All 20 (100%) hemoglobin spray-treated patients and 15 (75%) control patients experienced some wound healing by week 4, with 5 (25%) and 1 (5%), respectively, achieving complete wound closure. At week 4, mean wound size reduction was 63% in the hemoglobin spray group versus 26% for controls, increasing to 95% reduction at week 28 in the hemoglobin spray group versus 63% for controls (p<0.05 at all timepoints). Hemoglobin spray was associated with substantially lower pain scores using a 10-cm visual analogue scale, with 19/19 patients (100%) being pain-free from week 12 onwards, compared to 6/18 patients (33%) in the control group. At week 28, 2/18 patients (11%) in the control group still had pain. Both groups had similar baseline slough levels, but hemoglobin spray-treated wounds had slough completely eliminated after 4 weeks versus 10% mean reduction in the control group (p<0.001). Hemoglobin spray was associated with markedly reduced exudate levels; within 4 weeks, no patients had high exudate levels in the hemoglobin spray group versus 5 in the control group.

Conclusion: Standard wound care plus hemoglobin spray results in improvements in wound closure, wound size reduction, pain, slough, and exudate levels compared to control patients for chronic diabetic foot ulcer treatment.
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NewsBot · Mar 3, 2017

CLINICAL EFFECTIVENESS OF HEMOGLOBIN SPRAY (GRANULOX®) AS ADJUNCTIVE THERAPY IN THE TREATMENT OF CHRONIC DIABETIC FOOT ULCERS
Sharon D. Hunt, RGN, Dip, BSc Hons, MA and Fredrik Elg, PhLic, MSSc, MBA, BA, Dip Eng
Diabetic Foot & Ankle 2016, 7: 33101 - http://dx.doi.org/10.3402/dfa.v7.33101

Introduction: Hemoglobin spray (Granulox®) comprises purified hemoglobin and is a novel approach for increasing oxygen availability in the wound bed in diabetic foot ulcer patients. Its mode of action is to bind oxygen from the atmosphere and diffuse it into the wound bed to accelerate wound healing in slow-healing wounds.

Patients and methods: Wound healing outcomes, that is, wound size, pain, percentage of slough, and exudate levels, were compared retrospectively to a similar cohort of patients treated over the same period the previous year. The same inclusion and exclusion criteria applied to both groups.

Results: All 20 (100%) hemoglobin spray-treated patients and 15 (75%) control patients experienced some wound healing by week 4, with 5 (25%) and 1 (5%), respectively, achieving complete wound closure. At week 4, mean wound size reduction was 63% in the hemoglobin spray group versus 26% for controls, increasing to 95% reduction at week 28 in the hemoglobin spray group versus 63% for controls (p<0.05 at all timepoints). Hemoglobin spray was associated with substantially lower pain scores using a 10-cm visual analogue scale, with 19/19 patients (100%) being pain-free from week 12 onwards, compared to 6/18 patients (33%) in the control group. At week 28, 2/18 patients (11%) in the control group still had pain. Both groups had similar baseline slough levels, but hemoglobin spray-treated wounds had slough completely eliminated after 4 weeks versus 10% mean reduction in the control group (p<0.001). Hemoglobin spray was associated with markedly reduced exudate levels; within 4 weeks, no patients had high exudate levels in the hemoglobin spray group versus 5 in the control group.

Conclusion: Standard wound care plus hemoglobin spray results in improvements in wound closure, wound size reduction, pain, slough, and exudate levels compared to control patients for chronic diabetic foot ulcer treatment.
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NewsBot · Sep 18, 2019

Assessment of clinical effectiveness of haemoglobin spray as adjunctive therapy in the treatment of sloughy wounds.
Hunt SD, Elg F, Percival SL
J Wound Care, 2018 Apr 2;27(4):210-219

OBJECTIVE:
To assess use of an adjunctive topical haemoglobin spray in the treatment of sloughy wounds.

METHOD:
In addition to a standard wound care regimen, consecutive patients with sloughy wounds self-administered haemoglobin spray treatment twice a week until the wound was healed. All patients were followed-up for 26 weeks. Results were compared with a retrospective cohort of 100 consecutive patients, treated during the same period the previous year with standard wound care alone. Data were collected on wound characteristics including percentage of slough, exudate levels, wound pain, and wound size.

RESULTS:
After 26 weeks, 94/100 patients (94%) treated with haemoglobin spray were completely healed compared with 63/100 control patients (63%). Positive results were evident as early as week one with 52% mean wound size reduction using the heamoglobin spray versus 11% in the retrospective control (p<0.001). At baseline, mean slough coverage was higher in the haemoglobin group, 58% versus 44% in the control group (p<0.001). By week four, mean slough coverage was 1% in the haemoglobin versus 29% in the control group (p<0.001). Reductions in exudate and pain levels (p<0.001) were also observed.

CONCLUSION:
Overall, results of this evaluation showed the addition of adjunctive haemoglobin spray to standard wound care treatment achieved positive clinical outcomes for patients self-managing complicated sloughy wounds, by supporting reduction of wound exudate and slough within the complex multifaceted process of wound healing.
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NewsBot · Mar 14, 2020

Assessment of Acceptability and Ease of Use of Haemoglobin Spray (Granulox®) in the Management of Chronic Wounds
Kröger K, Gäbel G, Juntermanns B
Chronic Wound Care Management and Research » Volume 7

Wound healing is a complex and orchestrated process. Oxygen is one of the molecules that is required throughout the wound healing continuum for various underlying processes from innate immune response at the inflammatory phase to building of collagen type III at the remodelling phase. Therefore, it is not surprising that, due to primary diseases like venous insufficiency and diabetes mellitus, hypoxia caused by sustained lack of oxygen is common in chronic wounds. Adjunct to systemic therapies of the primary disease aimed at revascularizing the tissue, recently developed technologies are now available that provide topical oxygen-enhanced wound healing. Several devices are designed to provide pure oxygen directly to the wound either with or without pressure. Another approach to the provision of additional topical oxygen is to use haemoglobin to facilitate oxygen diffusion. This phenomenon was first shown more than 50 years ago, but it has only recently been discovered as a means of improving wound healing. In vitro and in vivo studies have shown that haemoglobin is capable of transporting oxygen outside of erythrocytes. Furthermore, several clinical studies have shown a beneficial effect on wound healing in different wound types. In this review, we summarise publicly available in vitro and in vivo clinical data and discuss the acceptability and ease of use of haemoglobin spray (Granulox®) in the management of chronic wounds. In conclusion, currently available data are promising, demonstrating that purified haemoglobin in an aqueous solution is able to serve as an oxygen shuttle by facilitating diffusion. No severe side effects have been reported in the literature, implying that it is a safe product. In clinical studies, it has been observed to improve the speed of healing of different types of chronic wounds. As a simple spray, it can be used as adjunct treatment in many standard-of-care settings with only a few limitations.
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NewsBot · May 20, 2020

Systematic review of the efficacy of topical haemoglobin therapy for wound healing
Jieman Hu Shaoning Guo Haiyan Hu Jianan Sun
First published: 19 May 2020 https://doi.org/10.1111/iwj.13392

Hypoxia is a common cause of poor wound healing, for which a variety of oxygen therapies have been developed. In order to overcome the limitations of traditional methods of treatment, namely the type of equipment, its setting, safety and cost, local haemoglobin therapy has been developed, although no reviews have so far been published. Here, we systematically review the current evidence to establish the efficacy, scope, adverse reactions, and required precautions of this new form of therapy. A search of the literature was conducted in the PubMed, Embase, Scopus, CENTRAL, CINAHL, and Web of science databases, with 17 studies meeting the eligibility criteria, comprising one animal model study and 16 clinical studies. Local haemoglobin therapy is able to safely and effectively promote the healing of a variety of wounds, especially those that are chronic and non‐healing. However, premature discontinuation of this treatment can result in impediment to wound healing and even deterioration of the wound. The distinct benefit of the elimination of slough and relief of pain suggests that this technique may represent a new generation of debridement technology. Furthermore, its ease of use and convenience enables patient self‐management, thereby greatly reducing health care costs.
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