Wound healing: total contact cast vs. custom-made temporary footwear for patients with diabetic foot ulceration. Off-loading the diabetic foot wound: a randomized clinical trial. Effects of integrating therapeutic touch into a cognitive behavioral pain treatment program. Report of a pilot clinical trial. A prospective randomized trial of autologous platelet-derived wound healing factors for treatment of chronic nonhealing wounds: a preliminary report. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. The effect of therapeutic touch on pain and anxiety in burn patients. Outcomes of touch therapies during bone marrow transplant. Stimulation of repair in chronic, nonhealing, cutaneous ulcers using platelet-derived wound healing formula. Antiplatelet agents in thrombotic thrombocytopenic purpura (TTP). Results of a randomized multicenter trial by the Italian Cooperative Group for TTP.
The objective of this study was to compare the effectiveness of irremovable total-contact casts (TCC) and custom-made temporary footwear (CTF) to heal neuropathic foot ulcerations in individuals with diabetes. In this prospective clinical trial, 43 patients with plantar ulcer Grade 1 or 2 (Wagner scale) were randomized to one of two off-loading modalities: TCC or CTF. Outcomes assessed were wound surface area reduction (cm2) and time to wound healing (days) at 2, 4, 8 and 16 weeks. To evaluate safety, possible side effects were recorded at each follow-up visit. The results showed no significant difference in wound surface area reduction (adjusted for baseline wound surface) at 2, 4, 8 or 16 weeks (adjusted mean difference 0.10 cm2; 95% CI -0.92-0.72 at 16 weeks). At 16 weeks, 12 patients had a completely healed ulcer, 6 per group. The median time to healing was shorter for the patients using a cast (52 vs. 90 days, p = 0.26). Five patients with TCC and two with CTF developed device-related complications. It was concluded that: (i) the rate of wound healing is not significantly different for patients treated with CTF or TCC. The difference in wound surface area was small and not significant at any time during follow-up; and (ii) the difference in healing time (38 days) may have attained statistical significance if the numbers in these sub-groups (2 x 6) had been higher. Since there appears to be little difference in effectiveness between both off-loading modalities, further investigation into the benefits of CTF is warranted. To compare the effectiveness of total-contact casts (TCCs), removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes.
                In this prospective clinical trial, 63 patients with superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one of three off-loading modalities: TCC, half-shoe, or RCW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound healing at 12 weeks and activity (defined as steps per day).
                The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities (89.5 vs. 61.4%, P = 0.026, odds ratio 5.4, 95% CI 1.1-26.1). There was also a significant difference in survival distribution (time to healing) between patients treated with a TCC and both an RCW (P = 0.033) and half-shoe (P = 0.012). Patients were significantly less active in the TCC (600.1 +/- 320.0 daily steps) compared with the half-shoe (1,461.8 +/- 1,452.3 daily steps, P = 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 +/- 563.3 daily steps, P = 0.67) or the RCW and the half-shoe (P = 0.15).
                The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe. The purpose of this study was to investigate the effects of offering Therapeutic Touch (TT) as an adjunct to cognitive behavioral therapy (CBT) for people with chronic pain. Patients were randomized to relaxation training (control group) or TT plus relaxation (experimental). Subsequently, all participants attended a CBT program. Preprogram and postprogram data were examined to identify patterns of change in pain intensity, self-efficacy, unitary power, disability, and perceived distress. In addition, patterns of attrition were examined. Patients in this study who were randomized to receive TT fared better in terms of enhanced self-efficacy and unitary power, as well as having lower attrition rates. Trends associated TT with less distress and disability. This pilot study suggests that offering TT as an adjunct to CBT may help to improve clinical outcomes, reduce program attrition, and promote unitary power in those who suffer with chronic pain. Previous studies have suggested that topically applied platelet-derived wound healing factors (PDWHF) accelerate wound healing by stimulating angiogenesis, fibroblast proliferation, and collagen synthesis. To assess the ability of platelet factors to facilitate healing of chronic cutaneous ulcers we performed a randomized, prospective, double-blind, placebo-controlled study of topical PDWHF in 18 patients with 26 lower extremity wounds refractory to conventional therapy. Wounds were present for at least 8 weeks (mean, 5.5 +/- 4.3 months). They were extensively debrided initially and were measured and photographed at weekly intervals for 12 weeks. Eight patients with nine wounds were treated with placebo solution (controls), and 10 patients with 17 wounds were treated with PDWHF (treatment group). Seventy-eight percent of patients had diabetes mellitus, 72% had occlusive peripheral vascular disease, and 28% had venous disease; distribution of these disorders was equivalent in both groups. Ankle-brachial indexes, which were often spuriously elevated, averaged 0.93 +/- 0.54 in controls and 1.04 +/- 0.56 in patients treated with PDWHF (p greater than 0.5). Mean transcutaneous oxygen tension was 37.8 +/- 11.9 mmHg in controls and 37.1 +/- 9.1 mmHg in patients treated with PDWHF. Initial wound area was larger in controls than in the patients treated with PDWHF (28.9 +/- 45.2 cm2 vs 13.0 +/- 4.4 cm2), but this difference was not statistically significant (p = 0.19). Three (33%) wounds (in two patients) healed in controls, and four (24%) wounds (in three patients) healed in the PDWHF group (p greater than 0.5). The rate of healing in controls was 1.9 +/- 2.7 cm2/week.(ABSTRACT TRUNCATED AT 250 WORDS) The purpose of this study was to evaluate the effectiveness of a removable cast walker (RCW) and an "instant" total contact cast (iTCC) in healing neuropathic diabetic foot ulcerations.
                We randomly assigned 50 patients with University of Texas grade 1A diabetic foot ulcerations into one of two off-loading treatment groups: an RCW or the same RCW wrapped with a cohesive bandage (iTCC) so patients could not easily remove the device. Subjects were evaluated weekly for 12 weeks or until wound healing.
                An intent-to-treat analysis showed that a higher proportion of patients had ulcers that were healed at 12 weeks in the iTCC group than in the RCW group (82.6 vs. 51.9%, P = 0.02, odds ratio 1.8 [95% CI 1.1-2.9]). Of the patients with ulcers that healed, those treated with an iTCC healed significantly sooner (41.6 +/- 18.7 vs. 58.0 +/- 15.2 days, P = 0.02).
                Modification of a standard RCW to increase patient adherence to pressure off-loading may increase both the proportion of ulcers that heal and the rate of healing of diabetic neuropathic wounds. The purpose of this single-blinded randomized clinical trial was to determine whether therapeutic touch (TT) versus sham TT could produce greater pain relief as an adjunct to narcotic analgesia, a greater reduction in anxiety, and alterations in plasma T-lymphocyte concentrations among burn patients. Therapeutic touch is an intervention in which human energies are therapeutically manipulated, a practice conceptually supported by Rogers' (1970) theory of unitary human beings. Data were collected at a university burn centre in the south-eastern United States. The subjects were 99 men and women between the ages of 15 and 68 hospitalized for severe burns, and they received either TT or sham TT once a day for 5 days. Baseline data were collected on day 1, data were collected before and after treatment on day 3, and post-intervention data were collected on day 6. Instruments included the McGill Pain Questionnaire, Visual Analogue Scales for Pain, Anxiety and Satisfaction with Therapy, and an Effectiveness of Therapy Form. Blood was drawn on days 1 and 6 for lymphocyte subset analysis. Medication usage for pain in mean morphine equivalents, and mean doses per day of sleep, anxiety and antidepressant medications were recorded. Subjects who received TT reported significantly greater reduction in pain on the McGill Pain Questionnaire Pain Rating Index and Number of Words Chosen and greater reduction in anxiety on the Visual Analogue Scale for Anxiety than did those who received sham TT. Lymphocyte subset analyses on blood from 11 subjects showed a decreasing total CD8 + lymphocyte concentration for the TT group. There was no statistically significant difference between groups on medication usage. The integration of complementary modalities into mainstream healthcare is gaining increasing emphasis. It is important, therefore, to document the effects of these interventions on patient outcomes.
                To investigate the effects of Therapeutic Touch and massage therapy on the outcomes of engraftment time, complications, and perceived benefits of therapy during bone marrow transplant.
                Randomized clinical trial.
                Subjects were adult patients on the bone marrow transplant unit of a large urban tertiary care center.
                Subjects were randomly assigned to 1 of 3 treatment groups: Therapeutic Touch (TT), massage therapy (MT), and a control group called the friendly visit (FV). Subjects (N = 88) were stratified by type of transplant (allogeneic or autologous). Twenty-seven subjects received MT; 31 received TT; and 30 received FV. Nurses with expertise in the 2 touch therapies administered them. The interventions of MT, TT, and FV were administered according to standarized protocols every third day beginning the day chemotherapy began until discharge from the program.
                Time for engraftment, complications, and patient perceptions of benefits of therapy were the main outcome measures. Analysis of variance and analysis of covariance were used to determine significant differences among the 3 groups with respect to time of engraftment.
                A significantly lower score for central nervous system or neurological complications was noted for subjects who received MT comppared with the control group; however, no differences were found among the 3 groups with respect to the other 10 complication categories or in the total mean score for complications. Patients' perception of the benefits of therapy (total score) was significantly higher for those who received MT compared with the FV control group. The mean scores on the comfort subscale were significantly higher for patients receiving both MT and TT compared with the FV control group.
                Massage therapy may be effective in altering the psychological and neurological complications associated with chemotherapy during bone marrow transplant. Both massage and Therapeutic Touch provide comfort to patients undergoing this challenging process. Chronic, nonhealing, cutaneous ulcers are a serious clinical problem. The results of previous studies using platelet-derived wound healing formula (PDWHF), derived from autologous platelets, provided evidence that PDWHF actively stimulates repair of the wound. To test whether or not PDWHF accelerates repair, a prospectively randomized, blinded trial was conducted using a placebo control. A total of 32 patients with chronic, nonhealing, cutaneous wounds of the lower extremity were randomized and treated for eight weeks with PDWHF or placebo. Epithelialization of the wound was the end point of study. In the group who received treatment, 81 per cent of patients had epithelialization in eight weeks compared with 15 per cent in the control group (p less than 0.0001). After crossover to treatment with PDWHF, all of the patients in the control group had epithelialization in an average of 7.1 weeks. Regression analysis of the rates of epithelialization also showed significant differences during the initial eight week trial and showed no difference after crossover of the control group to therapy with PDWHF. Results from this study demonstrate a highly statistically significant effect of topically applied platelet-derived growth factors on the repair of chronic, nonhealing, cutaneous ulcers. Antiplatelet agents are often included in plasma exchange-based regimens for thrombotic thrombocytopenic purpura (TTP) patients; however, the opportuneness of their use in TTP is still controversial. The italian Cooperative Group for TTP carried out a randomized trial to investigate their actual effectiveness, both in acute TTP and as maintenance treatment.
                Seventy-two TTP patients were randomized to receive plasma exchange and steroids with (group B) or without (group A) aspirin and dipyridamole. Treatment efficacy was evaluated after 15 days and salvage treatments were also considered for non-responders. Upon disease remission, the patients already treated with antiplatelet agents received ticlopidine for one year.
                Regarding the treatment of acute phase TTP, similar overall response rates were observed in the two groups (91.4% in group B vs. 75.6% in group A), but lower mortality rates were observed at 15 days in the patients treated with antiplatelet agents; as a matter of fact, 5 patients from arm A died in the first 15 days (13.5%) versus only one in arm B (2.8%). These figures, while not statistically significant, seem to suggest that antiplatelet agents might be useful in preventing deaths in acute TTP; moreover, bleeding did not worsen in antiplatelet agent-treated patients. As for the role of maintenance treatment, our results support the efficacy and safety of one-year ticlopidine therapy since the current relapse rate is significantly higher in non-treated patients; as a matter of fact, 6 patients (21.4%) in the non-ticlopidine group and only 2 (6.25%) in the ticlopidine group relapsed (P = .0182 in favor of maintenance treatment).
                Our results suggest the usefulness of antiplatelet agents in the treatment of acute phase TTP patients. Moreover, one-year ticlopidine maintenance therapy appears to be beneficial in preventing TTP relapses; however, only the completion of an adequate follow-up for all patients will definitively confirm this observation.
There is no robust evidence that TT promotes healing of acute wounds.