Effects of Early Mobilization on Unhealed Dysvascular Transtibial Amputation Stumps: A Clinical Trial

Article Outline

• Abstract
• Methods
• Results
• Discussion
  • Trial Confirms Our Hypotheses
    • Early mobilization can be undertaken without harm to the patient
    • Early mobilization has positive benefits for the patient
    • Early mobilization may influence the time taken to achieve healing and wound quality
  • Our Research Poses Some Questions
    • Why do amputation stumps break down after surgery?
    • What factors may influence stump wound healing?
    • What are the roles of transcutaneous pressures of oxygen/carbon dioxide (TcpO2/CO2)?
    • Can this trial influence surgical decision making?
• Conclusions
• Acknowledgments
• References
• Copyright

Abstract 

VanRoss ER, Johnson S, Abbott CA. Effects of early mobilization on unhealed dysvascular transtibial amputation stumps: a clinical trial.

Objective

To observe the effects of early mobilization on unhealed transtibial (TT) amputation stump wounds of dysvascular etiology. An “unhealed” stump was defined as having a wound greater than 1cm × 1cm at least 3 weeks after surgery.

Design

An observational cohort study.

Setting

This center receives about 250 new lower-limb amputees a year from over 50 surgeons working in 16 hospitals. Over 35% are unhealed.

Participants

Sixty-six consecutive new TT amputees (age 62.8±10.8y) of dysvascular etiology (diabetes 50%) with unhealed stumps were recruited. Sixty-one percent were current or past smokers. The mean ± SD stump wound size was 7.7±2.7cm × 3.2±2.0cm.

Interventions

The wound size was measured, and stump transcutaneous oxygen (TcpO₂) and transcutaneous carbon dioxide (TcpCO₂) were measured. Wounds were debrided and dressed by using a standard protocol. Mobilization using a Pneumatic Post-Amputation Mobility (PPAM) Aid for approximately 3 weeks was followed by provision of a TT prosthesis. A standard physiotherapy walking training program was performed.

Main Outcome Measures

Stump wound healing, time to achieve healing, and resting transcutaneous oxygen pressure pre- and posttherapy.

Results

Of the 66 amputees, 4 did not start. Sixty-two started; 6 withdrew, and 56 completed the trial. Complete wound healing was achieved in 74% (46/62) over a mean of 141 (87–270) days. The mean ± SD stump TcpO₂ at baseline was 41.3±19.8mmHg and increased significantly to 50.6±21.9mmHg (P<.02) after 97 (34–185) days of mobilization. Nine of 46 required revision plastic surgery. Five subjects, whose wounds were healing, became unwell, dropped out, and later deceased. Five subjects, all current smokers, did not heal and underwent higher amputation.

Conclusions

Patients with large unhealed TT stump wounds can simultaneously undergo walking training by using a prosthesis and can achieve wound healing. Seventy-four percent of subjects achieved full wound healing. The small minority of patients who did not heal were current smokers whose TcpO₂ levels did not improve throughout the trial. Rising levels of stump TcpO₂were associated with wound healing.

Key Words: Amputation stump, Mobilization, Rehabilitation, Wound healing

List of Abbreviations: PPAM, Pneumatic Post-Amputation Mobility, TcPCO₂, transcutaneous carbon dioxide, TcPO₂, transcutaneous oxygen, TF, transfemoral, TT, transtibial

PRESERVATION OF THE KNEE is a major factor determining the outcome after lower-limb amputation. Studies confirm that the TT (below the knee) amputee achieves superior function using less energy with a prosthesis,¹, ² improved longevity,², ³ and lower dependency on family and state as compared with the TF (above the knee) amputee. Knee preservation should be a major objective of the amputating surgeon.⁴

In practice, the surgeon treating patients with critical limb ischemia faces 2 serious clinical dilemmas: (1) no completely reliable test is available to determine whether sufficient blood supply is present to allow an amputation (performed at any level) to heal and (2) no completely reliable test is available to determine whether an unhealed amputation stump will proceed to healing.

It is commonly thought, despite some evidence to the contrary,², ³ that a more proximal TF amputation has a better chance of healing compared with a distal TT amputation. Applying this information, a surgeon treating an elderly patient with a dysvascular limb may be persuaded to perform a TF amputation, leaving the patient seriously disadvantaged.

Under ideal circumstances, the stump heals completely at about 2 weeks after surgery. However, should the stump fail to heal, no established treatment protocols exist. In cases of dysvascularity, the healing is more uncertain, and a “wait-and-see” strategy is often adopted. Dressings are applied to the wound, and all mobilization and walking therapy cease. This inactivity may go on for months until healing is achieved or a more proximal amputation is performed. Meanwhile, the patient becomes deconditioned and demoralized and may develop joint contractures.

Our subregional center receives about 250 new lower-limb amputee referrals per year, of which about 35% are unhealed. It is useful to document our first case with a “large” unhealed stump wound as an example.

Patient 1 was an 85-year-old man who suffered with diabetes-related neuropathy and critical ischemia of the left foot and underwent a TT amputation on December 28, 1996. The stump wound broke down, becoming necrotic and odorous. Surgeons advised revision to a TF amputation. The patient was determined not to have any further surgery. He was aware that having an above-the-knee amputation would seriously impair his mobility and require lifestyle modification. The patient requested that he be measured for a prosthesis over his wound dressing. He felt little pain and was keen to be given an opportunity to mobilize. After discussion with the rehabilitation team and with some trepidation, he was allowed to mobilize and was supplied with his prosthesis. The photographs (fig 1) show progression to complete healing. The patient continued to use his prosthesis daily and to mobilize with the aid of 2 walking sticks within the house and for short distances outdoors until his death in December 2007.

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• Fig 1. 

  Patient 1, aged 85 years. Left TT amputation12-28-96 for Diabetes/PVD. Mobilization began on January 28, 1997. Wound healing and walking training was completed May 29, 1997. Deceased December 2007. (Presented with permission).

Based on this experience, our practice evolved to allow new amputee patients with small unhealed wounds to mobilize, but gradually patients with larger wounds were accepted. We reviewed 25 patients with unhealed stumps who had mobilized on a prosthesis and had sucessfully proceeded with their rehabilitation. Wound healing was achieved in all cases. A literature review revealed no validated guide to treat the unhealed dysvascular amputation stump.

Based on this information, ethical approval (Health Authority Ethics Committee Ref: SOU/99/085) was obtained to allow a prospective trial to mobilize dysvascular amputees with unhealed TT stumps. Our hypothesis was that it would be safe to mobilize patients with unhealed amputation stumps. Mobilization would not harm the unhealed stump but would possibly aid in healing. There could be physical and psychological benefits to the patient.

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Methods 

An unhealed stump was defined as having a wound greater than 1cm × 1cm at least 3 weeks after surgery. A healed stump was defined as no wound, no discharge, and no dressing.

All new inpatient and outpatient cases (referred to the lead author) who were TT amputees of dysvascular etiology with unhealed stumps were offered enrollment in the trial. A stump with bone exposed was not a cause for exclusion. Exclusions were as follows: (1) persons unable to work with the team for other medical reasons (eg, angina at rest or severe ischemia of the contralateral foot), (2) persons who were cognitively impaired or unable to give consent, (3) persons who did not wish to undertake the trial, and (4) persons who were otherwise deemed unsuitable for rehabilitation with a prosthesis (eg, unfitable fixed flexion contracture of the knee joint).

Established users of a prosthesis (TF andTT) who presented with an unhealed second-limb amputation were allowed to participate in the trial. Participants were given full information in a printed leaflet. Signed consent was provided by each partcipant. The following protocol was performed:

When prescribed, antibiotics were used in short courses of 7 to 10 days only. For cellulitis, a penicillin-based antibiotic was used as a first-line treatment. Positive deep cultures were treated with the appropriate antibiotics. Malodorous wounds were treated with a 7-day course of metronidazole. Saprophytic bacterial contamination (including methicillin-resistant Staphylococcus aureus) was not treated with antibiotics. Only oral antibiotics were used, and no patient required intravenous delivery.

Subjects left the trial when any of the following occurred: (1) complete wound healing, (2) wound deterioration of greater than 10%, (3) the development of systemic signs of toxicity, (4) a request from the patient that their trial be suspended, (5) the team considered that undue risk was being taken, and further mobilization was futile (eg, the development of fixed knee joint contracture).

For the statistical analyses, data were expressed as mean ± SD, number, or percentage prevalence. Statistical analyses were performed by the Student t test using the Microsoft Office Excel 2003 package.

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Results 

Sixty-six patients were formally enrolled on the trial and signed the appropriate consent forms. The patients' characteristics are given in table 1. Four patients withdrew consent before the trial started: 2 changed their minds, 1 developed an embolus resulting in an extremely ischemic below-knee stump that required an above-knee amputation, and 1 developed more than 40° of fixed flexion deformity of the knee. The remaining 62 patients began the trial. Six of the patients (10%) withdrew from the study once they started (1 developed 40° fixed flexion at the knee, 4 developed poor general health, 1 was noncompliant) (table 2).

Table 1. Baseline Characteristics of Participants

Number	66
Male:female	46:20
Age (y)	62.8±10.8
Site of amputation
L TT	40
R TT	26
Bilateral amputees (n=8)
TT	7
TF	1
Ethnic origin
White European	64
African Caribbean	1
Algerian	1
Diabetes mellitus (%)	33(50.0)
Body mass index	25.2±6.0
Smoking (%)
Current	23(34.8)
Ex	17(25.8)
Never	21(31.8)
Unknown	5(7.6)

NOTE. Data are expressed as number, mean ± SD, or percent.

Table 2. Outcome of All Participants

Total participants	66
Nonstarters (withdrawn)	4
Total begining trial (%)	62(100)
Withdrawn (ill health, noncompliant, contracture) (%)	6(10)
Total completing trial (%)	56(90)
Healed	46(74)
Deceased	5(8)
Nonhealing	5(8)

Fifty-one patients (82%) maintained regular mobilization according to the protocol and made significant improvements toward stump wound healing. Forty-six patients (74%) with a mean ± SD baseline stump wound size of 7.4±3.2cm × 3.5±2.4cm achieved complete stump wound healing after 141 (87–270) days (median interquartile range) of mobilization therapy. Five patients who showed signs of healing became unwell, stopped attending, and died before healing was complete. Nine of the 46 subsequently required local plastic surgical revision and then proceeded to heal by primary intention. Reasons for revision surgery were prominent bone end (3 cases), adherent scar (4 cases), and bone protrusion through the healed stump (2 cases). When the tibia protruded through the wound, mobilization was continued until epithelialization around the bone was complete. At surgery, the bone was trimmed back, and primary closure of the wound was achieved (fig 3).

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• Fig 3. 

  Patient 2, aged 77 years. Left TT amputation for PVD 8-8-99. Enrolled trial October 8, 1999 TcpO₂ 20mmHg. Started PPAM aid October 8, 1999. First prosthesis October 22, 1999. On January 24, 2000 TcpO₂ 57mmHg. Revision surgery March 16, 2000. No antibiotics used (except perioperatively). Analgesics: tramadol hydrochloride. Completed wound healing and walking training May 28, 2000. Community walker with 1 stick. Deceased April 2007.

Five patients (8%) failed to heal and eventually progressed to a TF amputation. The mean resting stump TcpO₂at baseline was 41.3±19.8mmHg, which increased significantly to 50.6±21.8mmHg (P<.01) after 97 (34-185) days of mobilization therapy. The 5 patients who failed to heal were all current smokers, consuming 23.3 cigarettes per day (mean). The mean ± SD baseline TcpO₂ level for these unhealed stumps was 45.1mmHg, which decreased to 34.0mmHg after mobilization therapy.

The effect of smoking on stump TcpO₂ was further evident when we examined skin oxgen levels in nonsmokers versus current smokers. The mean TcpO₂ levels for nonsmokers improved significantly after therapy (P<.01), whereas levels for current smokers did not change (table 3). Furthermore, wound healing was achieved in 94% of nonsmokers compared with just 63% of current smokers (P=.006). Time to healing was no different between the 2 groups (196±142d vs 200±123d, respectively).

Table 3. Change in Resting Stump TcpO₂ From Baseline to Postmobilization Therapy

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Discussion 

In this study, an early mobilization program beginning with the Pneumatic Post-Amputation Mobility Aid and quickly progressing to a prosthesis appears to be a successful therapy for unhealed dysvascular transtibial amputation stumps. Patients who would otherwise be inactive received walking training, and three quarters of all patients subsequently achieved full wound healing. Furthermore, patients who healed successfully had local TcpO₂ levels that improved significantly after therapy, whereas nonhealing was associated with current smoking and TcpO₂ levels that failed to improve.

Trial Confirms Our Hypotheses 

The elderly dysvascular amputee is extremely vulnerable and usually has multiple additional medical complications but, most particularly, cardiopulmonary pathology and ischemic changes in the contralateral limb. People with diabetes have reduced immunity.

During the course of this trial, subjects were monitored very closely. No harm was observed to the stump wounds or the contralateral limb, and, indeed, the benefits of exercise were generally appreciated.

Five subjects (8%) died during the course of the trial. All 5 showed signs of healing, stopped attending, and subsequently died from cardiorespiratory pathology. No acute cardiac events were recorded during walking training sessions. A mortality rate of 8% is perhaps to be expected when compared with a postamputation 1–year mortality rate of about 30% to 40% reported in other series.⁶, ⁷

Much of the protocol is contrary to natural caution and traditional medical teaching. Some members of the multidisciplinary rehabilitation team were initially sceptical and believed the trial was inhumane, possibly harmful, and excessively demanding on the patient. However, very soon, all of the team members became very positive and encouraging regarding the trial.

Patients wished to participate in the trial and take an active part in their recovery. The most important benefit of this trial was that wounds healed and patients learned to walk simultaneously and without delay. Problems caused through immobility were not observed. Deconditioning of muscles and formation of contractures were avoided (except in 1 case). Patients were discharged from hospital at the earliest possible opportunity and received treatment as outpatients. This was a psychologic boost for the patient and cost-effective for the health service.

The time taken to complete wound healing can be quite prolonged, especially in those requiring revision surgery. It is not possible from the results of this trial to claim that the time to wound healing was either hastened or delayed. However, even if the time to healing was increased, it has probably been marginal and outweighed by the benefits of early mobilization.

The excellent quality of the healed wound was a pleasing outcome. It is interesting to note that even very large wounds healed producing very acceptable healthy scars (fig 4). The scar appearance and durability matched scars healed by primary intention. The quality of the scar was attributed to mobilization, causing a rapid shrinkage in the stump volume that reduces the tension in the wound and probably allows the skin margins to come together quite naturally. Compression socks and total-contact prosthetic sockets prevented scar hypertropy.

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• Fig 4. 

  Patient 3, aged 52 years. Hypertension induced end stage renal failure on ambulatory peritoneal dialysis. PVD leading to right TT amputation September 21, 2006. Entered trial October 9, 2006 with TcpO₂ 44mmHg. First prosthesis: November 23, 2006. Wound healing and walking training completed February 9, 2007. No antibiotics were used. Currently a community ambulator using 1 stick; awaiting renal transplant.

Our Research Poses Some Questions 

With a history of dysvascularity, it is assumed that stumps do not heal after surgery because of insufficient blood supply. Associated factors given are smoking, hemorrheology, malnutrition, previous vascular surgery, diabetes mellitus, absence of preoperative gangrene, level of amputation, prophylactic antibiotics, surgical technique and experience, drains, and dressing.⁸

The experience of the surgical team may be a key factor. The ratio of TT to TF amputation shows marked variance between surgeons⁹ even within the same surgical unit. Harris et al¹⁰ reported that they were able to reverse their TT:TF ratio of 1:6 in 1964 to 3:1 by 1982 by implementing changed surgical practice. Thus, experience in patient management and surgical technique is crucial in achieving wound healing. It may also explain why failure to heal by primary intention may occur despite adequate TcpO₂ levels.¹¹

We observed that most stumps break down in the soft tissue directly over the distal tibia (see Fig 3, Fig 4), whereas the adjacent margins of the wound are healed. We speculate, in these cases, that adequate blood supply must have existed to allow a part of the wound to heal, but perfusion to the skin over the tibia was compromised either through undue tension of skin closure at the time of surgery or by a postsurgical pathophysiologic process inducing high tissue tension and swelling, causing the buildup of enough pressure to exsanguinate and devitalize the covering soft tissue.

One factor is early mobilization. Immediate postoperative fitment was used successfully more than 50 years ago.¹², ¹³ In 1970, Sarmiento et al¹⁴ reviewed 625 amputees fitted with temporary prostheses after surgery and found that immediate postoperative fitting “reduced pain, reduced the time for stump shrinkage, permitted earlier permanent fitting, and improved the psychological outlook”. However, prosthetic fitment and mobilization were abandoned when there were signs of wound infection or wound breakdown. Pinzur et al¹⁵ in 1988 reported on 10 patients with failing below-knee amputations who were treated by total contact casting and continued weight-bearing ambulation. They noted that all 10 completely healed.

Another factor that may influence stump wound healing is exercise. Nearly all subjects suffering with limb ischemia have been relatively immobile for a considerable period of time before amputation. Exercise aims to reverse the effects of prolonged inactivity. Exercise has a central and peripheral effect. The central effect has been demonstrated when upper-limb cycling exercises¹⁶ have shown an equally beneficial effect on claudication distance as the traditional lower-limb walking exercises¹⁷. This suggests that improved cardiac output may play a major part in perfusion of the limb. The peripheral effect of exercise improves stamina, avoiding muscle deconditioning and joint contractures.

In our study, the additional benefit of walking with a prosthesis induced stump shrinkage and, therefore, a reduction in total volume of the stump. This inevitably reduces tissue tension over the wound margins. It is also known that the presence of edema reduces measured TcpO₂ in a limb.¹⁸ Our observed increase in TcpO₂ in stumps may be attributed to reduced edema in conjunction with a possible increase in blood perfusion to the limb. Improved outcomes after the use of immediate postoperative rigid casts are attributed to the primary prevention of swelling and edema after surgery, which may explain the improved healing when compared with traditional soft dressings.¹⁹

The combination of compression and mobilization may also be a factor in stump wound healing. Our study brought together stump compression and mobilization (on a PPAM Aid first followed by a prosthesis). Every step causes intermittent compression to the stump, which may have the same effect as a vacuum force applied to the wound by producing large ammounts of wound exudate. We believe that wound exudate reduces edema and acts as a douche to wash out contaminants, besides irrigating the wound with useful nutrients, growth factors, and enzymes. This hypothesis requires further research.

Smoking may also play a role in stump wound healing. The negative effect of current smoking on lower-limb amputation healing has been identified elsewhere, with primary amputees showing a 2.5-fold increased risk of reamputation compared with nonsmokers.²⁰ Our results support this; furthermore, we have shown that current smoking negates much of the benefits of mobilization on achieving full wound healing. It is likely that smoking impairs local TcpO₂ levels and prevents any improvement posttherapy via the inhibitory effect of high serum nicotine concentrations on skin microvascular function.

TcpO₂ has been previously identified as an indicator of local ischemia and stump wound healing.²¹ We found that a significant rise in TcpO₂ was associated with successful wound healing. It should be emphasized that in this trial decision making was based on clinical assessment and examination rather than TcpO₂measurement.

We believe there is a definite place for TcpO₂ measurement. Static 1-time measures are probably of little value. Serial measurements²² that show a rise in O₂ levels could be more useful and encouraging to the clinic team to continue with its efforts. The proper use of TcpO₂ in clinical practice should be determined by further clinical trials.

It is hoped this trial will influence surgical colleagues in 3 ways: (1) reviewing surgical technique, in particular, smoothening of the tibia in both planes. (2) preparing a viable myoplastic flap and suturing the wounds under physiological tension; and (3) performing more TT amputations, knowing that the unhealed stump is treatable in most cases.

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Conclusions 

By using early mobilization techniques, we have observed evidence of healing in 82% with completion of healing in 74% of dysvascular amputation stumps. No adverse effects to the stump or to the general health of the patient were observed. Furthermore, we have shown that successful wound healing is associated with increasing local TCpO₂ levels, whereas current smokers show no improvement in TCpO₂ levels after therapy. The healing rate of nonsmokers is almost double that of smokers even when the baseline TCpO₂ is low. Active smokers were most likely to fail to heal. A multidisciplinary rehabilitation team is essential for implementing early mobilization therapy. The process of stump wound healing and the role of TcpO₂ require further research.

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Acknowledgments 

We thank our research team, Gill Weaver, RGN, Cath Crawford, RGN, and Carolyn Hirons, MSc, Physiotherapist; Ragu Pabbineedi, MBBS, and Adam Garrow, PhD for their technical help; and Ken Dunn, FRCS, for his support, advice, and surgical skill.

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• a Polaroid Corporate Headquarters, 4400 Baker Rd, Minnetonka, MN 55343-8684.
• b Radiometer TCM4 Copenhagen, Manor Ct, Manor Rd, W Sessex, UK.
• c PPAM Aid (Pneumatic Post Amputation Mobility Aid), Ortho Europe, Mill Ln, Alton, Hampshire, UK.