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Biomedical subjects

Peter Sheehan

Publications and source records attributed to Peter Sheehan.

15 recordsLinked to original sources
PubMed2007

Talactoferrin alfa, a recombinant human lactoferrin promotes healing of diabetic neuropathic ulcers: a phase 1/2 clinical study.

BACKGROUND: Talactoferrin alfa, a recombinant form of human lactoferrin, is a novel immunomodulatory protein with demonstrated ulcer healing properties in animal models. METHODS: A phase 1/2 clinical study was conducted at 7 clinical sites to determine if talactoferrin can improve wound healing in diabetic patients with foot ulceration. Fifty-five patients with diabetic neuropathic foot ulcers participated in this 2-phase study. In phase 1, groups of 3 patients each received open-label 1%, 2.5%, or 8.5% talactoferrin gel twice daily, in a sequential design, to their ulcer for 30 days. No drug-related adverse events were found at any dose level. Phase 2 was a randomized, placebo-controlled, single-blind study of 2.5% and 8.5% gels, with patients equally divided between the 3 groups. In combination with good wound care, treatment was administered topically twice daily to the ulcers for 12 weeks. The primary endpoint was the incidence of > or = 75% healing (relative to baseline size). RESULTS: The study, which in phase 2 was powered to detect a difference between the placebo and combined talactoferrin arms with P < .1, met the primary objective. The groups receiving the 2.5% (n = 15) and 8.5% (n = 15) gels had twice the incidence of > or = 75% reduction in ulcer size compared with the placebo group (n = 16): 47%, 53%, and 25%, respectively. On an intent-to-treat basis, the combination of the 2 active groups when compared with the placebo group showed a strong trend toward statistical significance (P = .09). There were no talactoferrin-related adverse events or laboratory abnormalities. CONCLUSIONS: Topical talactoferrin appears to be safe and well tolerated and improves healing of diabetic neuropathic ulcers.

Administration, Topical↗
PubMed2006

Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial.

OBJECTIVE: To assess the ability of the 4-week healing rate to predict complete healing over a 12-week period in a large prospective multicenter trial of diabetic patients with foot ulceration. RESEARCH DESIGN AND METHODS: We examined the change in ulcer area over a 4-week period as a predictor of wound healing within 12 weeks in patients who were seen weekly in a prospective, randomized controlled trial. RESULTS: Wound area measurements at baseline and after 4 weeks were performed in 203 patients. The midpoint between the percentage area reduction from baseline at 4 weeks in patients healed versus those not healed at 12 weeks was found to be 53%. Subjects with a reduction in ulcer area greater than the 4-week median had a 12-week healing rate of 58%, whereas those with reduction in ulcer area less than the 4-week median had a healing rate of only 9% (P < 0.01). The absolute change in ulcer area at 4 weeks was significantly greater in healers versus nonhealers (1.5 versus 0.8 cm2, P < 0.02). The percent change in wound area at 4 weeks in those who healed was 82% (95% CI 70-94), whereas in those who failed to heal, the percent change in wound area was 25% (15-35; P < 0.001). CONCLUSIONS: The percent change in foot ulcer area after 4 weeks of observation is a robust predictor of healing at 12 weeks. This simple tool may serve as a pivotal clinical decision point in the care of diabetic foot ulcers for early identification of patients who may not respond to standard care and may need additional treatment.

Journal Article↗
PubMed2006

Evidence-based protocol for diabetic foot ulcers.

BACKGROUND: Diabetic foot ulcers are the single biggest risk factor for nontraumatic foot amputations in persons with diabetes. Foot ulcers occur in 12 to 25 percent of persons with diabetes and precede 84 percent of all nontraumatic amputations in this growing population. Because of the high incidence of foot ulcers, amputations remain a source of morbidity and mortality in persons with diabetes. Strict adherence to evidence-based protocols as described herein will prevent the majority of these amputations. METHODS: The collective experience of treating patients with neuropathic diabetic foot ulcers in four major diabetic foot programs in the United States and Europe was analyzed. RESULTS: The following protocol was developed for patients with diabetic foot ulcers: (1) establishment of good communication among the patient, the wound healing team, and the primary medical doctor; (2) comprehensive, protocol-driven care of the entire patient, including hemoglobin A1c, microalbuminuria, and cholesterol as well as early treatment of retinopathy, nephropathy, and cardiac disease; (3) weekly objective measurement of the wound with digital photography, planimetry, and documentation of the wound-healing process using the Wound Electronic Medical Record, if available; (4) objective evaluation of blood flow in the lower extremities (e.g., noninvasive flow studies); (5) débridement of hyperkeratotic, infected, and nonviable tissue; (6) use of systemic antibiotics for deep infection, drainage, and cellulitis; (7) off-loading; (8) maintenance of a moist wound bed; (9) use of growth factor and/or cellular therapy if the wound is not healing after 3 weeks with this protocol; and (10) consideration of the use of vacuum-assisted therapy in complex wounds. CONCLUSIONS: In diabetic foot ulcers, availability of the above modalities, in combination with early recognition and comprehensive treatment, ensures rapid healing, minimizes morbidity and mortality rates, and eliminates toe and limb amputations in the absence of ischemia and osteomyelitis.

Anti-Bacterial Agents↗
PubMed2006

Minimally invasive revascularization strategies for chronic lower limb ischemia.

Lower extremity wounds resulting from ischemia are increasingly becoming a common indication for surgical revascularization. Techniques in minimally invasive vascular surgery for the treatment of lower extremity chronic ischemia have expanded rapidly in recent years. The current standard of care with which all new modalities should be compared is the restoration of arterial flow via direct arterial revascularization using the autogenous reversed saphenous vein that can yield limb salvage rates of approximately 95%. Percutaneous transluminal angioplasty and stenting (PTA/S), cryoplasty, catheter-directed atherectomy, laser-assisted PTA/S, drug-eluting stents, and subintimal angioplasty are emerging minimally invasive modalities used for the treatment of lower extremity ischemia. Early success rates using many of these techniques have been promising. The outcomes of randomized controlled trials with long-term follow-ups are needed to make confident remarks about the effectiveness of these techniques.

Angioplasty↗
PubMed2006

Development of a content-validated venous ulcer guideline.

Evidence-based practice for venous ulcers may improve healing and reduce costs of care. The Association for the Advancement of Wound Care Government and Regulatory Task Force developed a content-validated venous ulcer guideline based on best available evidence supporting each aspect of venous ulcer care. After compiling all-inclusive lists of elements in venous ulcer algorithms published before August 2002, the Task Force objectively rated and summarized up to five best references from MEDLINE, CINAHL, and EMBASE literature searches covering each aspect of care. Sixteen multidisciplinary wound care professionals and educators used judgment quantification to content validate all steps. A 2004 email survey of AAWC members (N = 1,514) clarified effects of under-reimbursement on evidence-based venous practice. The Venous Ulcer Guideline containing all elements with A-level evidence plus those with a Content Validity Index >0.75 now resides on the AAWC and the Agency for Healthcare Research and Quality National Guideline Clearinghouse websites. However, a review of US healthcare environment components, including reimbursement policies, and the results of the survey identified many barriers to implementation of A-level evidence supported steps (sustained graduated high compression, autolytic debridement, and moist wound environments) in practice. Sufficient evidence supports improved venous ulcer care in the US but inadequate and/or inconsistent reimbursement policies impede quality evidence-based venous ulcer practice, delaying healing and increasing the burden of venous ulcers on society.

Algorithms↗
PubMed2005

Peripheral arterial disease: clinical assessment and indications for revascularization in the patient with diabetes.

Peripheral arterial disease (PAD) is an under-recognized complication of diabetes. Recently, prevalence estimates in patients with diabetes over 50 years of age have been placed at 25% to 30%. The main reason for under-reporting is the largely asymptomatic nature of PAD in diabetes. Nonetheless, it is important to diagnose PAD because it is a marker of systemic atherosclerosis with excess cardiovascular risk, and it may identify a patient who may develop progressive disability and risk of limb loss. The most sensitive and specific diagnostic tool is an ankle-brachial index. Imaging studies are performed in patients who are candidates for revascularization. The most durable and effective revascularization procedure for PAD in diabetes is surgical bypass with saphenous vein as the conduit. Endovascular interventions are best used in patients with proximal disease with short-segment stenoses. The indications for revascularization have been immutable for decades, namely rest pain, ischemic ulceration, or gangrene. Presently, clinicians would include "selected" patients with intermittent claudication who have disabling symptoms and proximal disease above the inguinal ligament.

Angioplasty↗
PubMed2004

Protocol for treatment of diabetic foot ulcers.

Each year, 82,000 limb amputations are performed in patients with diabetes mellitus. The majority of these amputations could be avoided by following strict protocols. The collective experience treating patients with neuropathic diabetic foot ulcers of 4 major diabetic foot programs in the United States and Europe were analyzed. The following protocol has been developed for patients with diabetic foot ulcers: (1) measurement of the wound by planimetry; (2) optimal glucose control; (3) surgical debridement of all hyperkeratotic, infected, and nonviable tissue; (4) systemic antibiotics for deep infection, drainage, and cellulitis; (5) offloading; (6) moist-wound environment; and (7) treatment with growth factors and/or cellular therapy if the wound is not healing after 2 weeks with this protocol and a new epithelial layer is not forming. In addition, the pathogenesis of diabetic foot ulcers is discussed, as well as the associated costs and complications, including amputation. Debridement, wound-bed preparation, antibiotics, various types of dressings, biological therapies, growth factors, and offloading are described as treatment modalities for patients with diabetic foot ulcers. In diabetic foot ulcers, availability of the above modalities, in combination with early recognition and comprehensive treatment, ensure rapid healing and minimize morbidity, mortality, and costs, as well as eliminate amputation in the absence of ischemia and osteomyelitis.

Biological Therapy↗
PubMed2003

Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial.

OBJECTIVE: To assess the ability of the 4-week healing rate to predict complete healing over a 12-week period in a large prospective multicenter trial of diabetic patients with foot ulceration. RESEARCH DESIGN AND METHODS: We examined the change in ulcer area over a 4-week period as a predictor of wound healing within 12 weeks in patients who were seen weekly in a prospective, randomized controlled trial. RESULTS: Wound area measurements at baseline and after 4 weeks were performed in 203 patients. The midpoint between the percentage area reduction from baseline at 4 weeks in patients healed versus those not healed at 12 weeks was found to be 53%. Subjects with a reduction in ulcer area greater than the 4-week median had a 12-week healing rate of 58%, whereas those with reduction in ulcer area less than the 4-week median had a healing rate of only 9% (P < 0.01). The absolute change in ulcer area at 4 weeks was significantly greater in healers versus nonhealers (1.5 vs. 0.8 cm(2), P < 0.02). The percent change in wound area at 4 weeks in those who healed was 82% (95% CI 70-94), whereas in those who failed to heal, the percent change in wound area was 25% (15-35; P < 0.001). CONCLUSIONS: The percent change in foot ulcer area after 4 weeks of observation is a robust predictor of healing at 12 weeks. This simple tool may serve as a pivotal clinical decision point in the care of diabetic foot ulcers for early identification of patients who may not respond to standard care and may need additional treatment.

Diabetic Foot↗
PubMed2002

A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers.

HYPOTHESIS: Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers. DESIGN: Randomized, prospective, controlled multicenter trial. SETTING: University teaching hospitals and primary care centers. PATIENTS: A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer. INTERVENTIONS: Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks. MAIN OUTCOME MEASURE: Complete healing of the study ulcer (wound). RESULTS: After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze. CONCLUSIONS: Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.

Adult↗
PubMedDate not supplied

Total-contact casting as an adjunct to promote healing of pressure ulcers in amputees.

Partial foot amputations have become increasingly prevalent among long-lived diabetic patients. These patients have lower extremity neuropathy and are prone to ulceration at their amputation site. These ulcers are difficult to heal, and they place a significant financial and resource burden on the healthcare system. We examined the efficacy of total-contact casts (TCC) in diabetic amputees with nonhealing partial foot amputation site neuropathic ulcers. Data were collected retrospectively on all patients with amputations who were treated with a total-contact cast between December 2000 and December 2003. Seventeen patients (13 men, 4 women) with amputation site ulceration were identified. All patients were diagnosed with neuropathy secondary to diabetes and none had wound healing compromised by ischemia. The initial ulcer averaged 1,169 mm(2) with a depth of 2.77 mm. Patients were treated with an average of 7.9 cast applications over 8.4 weeks; 47% (8/17) of ulcers healed, but 29% (5/17) of patients were unable to complete their recommended treatment course secondary to complications from the TCC. Of the patients who were able to complete their treatment course, the healing rate was 66.7% (8/12). The recurrence rate for healed ulcers was 63% (5/8). Partial foot amputations with neuropathic ulcers present a very difficult problem to the vascular surgeon. Patient compliance and underlying medical comorbidities limit the success rate. In patients who can complete a TCC treatment course, good short term results can be expected. However, recurrence rates are high following discontinuation of mechanical TCC off-loading.

Adult↗